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class="bkr_bib"><h1 id="_NBK581143_"><span itemprop="name">Evidence review: Antiseizure medication for status epilepticus</span></h1><div class="subtitle">Epilepsies in children, young people and adults: diagnosis and management</div><p><b>Evidence review 9</b></p><p><i>NICE Guideline, No. 217</i></p><p class="contrib-group"><h4>Authors</h4><span itemprop="author">National Guideline Centre (UK)</span>.</p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2022 Apr</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-4513-9</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2022.</div></div><div class="bkr_clear"></div></div><div id="niceng217er9.s1"><h2 id="_niceng217er9_s1_">1. Anti-seizure medication: Status epilepticus</h2><div id="niceng217er9.s1.1"><h3>1.1. Introduction</h3><p>Status epilepticus is a serious medical emergency characterised either by continued seizures or by a lack of full recovery between seizures. People with status epilepticus require urgent intervention to limit their risk of neurological harm and death, particularly from generalised tonic-clonic status epilepticus. Adherence to standard management protocols, including early intervention, is important to improve outcomes of status epilepticus in adults and children. Such protocols need to be built upon the best evidence to guide the most effective and timely interventions in both community and hospital settings. This review evaluates how to optimise care for people with status epilepticus up to the point of considering anaesthesia.</p></div><div id="niceng217er9.s1.2"><h3>1.2. Review question Monotherapy</h3><p>What anti-seizure medications (monotherapy) are effective in the treatment of status epilepticus?</p><div id="niceng217er9.s1.2.1"><h4>1.2.1. Summary of the protocol</h4><p>For full details, see the review protocol in <a href="#niceng217er9.appa">Appendix A</a>: section <a href="#niceng217er9.appa.s1">A.1</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab1"><a href="/books/NBK581143/table/niceng217er9.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab1" rid-ob="figobniceng217er9tab1"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab1/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab1/?report=previmg" alt="Table 1. PICO characteristics of review question." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab1"><a href="/books/NBK581143/table/niceng217er9.tab1/?report=objectonly" target="object" rid-ob="figobniceng217er9tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">PICO characteristics of review question. </p></div></div></div><div id="niceng217er9.s1.2.2"><h4>1.2.2. Methods and process</h4><p>This evidence review was developed using the methods and process described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. Methods specific to this review question are described in the review protocol in <a href="#niceng217er9.appa">appendix A</a> and the <a href="/books/NBK581143/bin/niceng217er9_bm1.pdf">methods</a> document.</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng217er9.s1.2.3"><h4>1.2.3. Effectiveness evidence</h4><div id="niceng217er9.s1.2.3.1"><h5>1.2.3.1. Included studies</h5><p>Twenty two studies assessing monotherapy in status epilepticus (SE) were included in the review<a class="bibr" href="#niceng217er9.ref5" rid="niceng217er9.ref5"><sup>5</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref7" rid="niceng217er9.ref7"><sup>7</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref10" rid="niceng217er9.ref10"><sup>10</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref13" rid="niceng217er9.ref13"><sup>13</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref38" rid="niceng217er9.ref38"><sup>38</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref41" rid="niceng217er9.ref41"><sup>41</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref57" rid="niceng217er9.ref57"><sup>57</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref59" rid="niceng217er9.ref59"><sup>59</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref87" rid="niceng217er9.ref87"><sup>87</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref110" rid="niceng217er9.ref110"><sup>110</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref112" rid="niceng217er9.ref112"><sup>112</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref115" rid="niceng217er9.ref115"><sup>115</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref125" rid="niceng217er9.ref125"><sup>125</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref126" rid="niceng217er9.ref126"><sup>126</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref128" rid="niceng217er9.ref128"><sup>128</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref130" rid="niceng217er9.ref130"><sup>130</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref187" rid="niceng217er9.ref187"><sup>187</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref189" rid="niceng217er9.ref189"><sup>189</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref215" rid="niceng217er9.ref215"><sup>215</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref217" rid="niceng217er9.ref217"><sup>217</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref221" rid="niceng217er9.ref221"><sup>221</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref239" rid="niceng217er9.ref239"><sup>239</sup></a>these are summarised in <a class="figpopup" href="/books/NBK581143/table/niceng217er9.tab2/?report=objectonly" target="object" rid-figpopup="figniceng217er9tab2" rid-ob="figobniceng217er9tab2">Table 2</a> below. Fifteen studies were in children, 3 in adults and 2 in adults and children. Three reports for one study have also been included. Evidence was found for the following interventions: diazepam, levetiracetam, lorazepam, midazolam, paraldehyde and valproate. The majority of the studies were conducted in the emergency department (ED). All studies assessed those with convulsive seizures. Evidence from these studies is summarised in the clinical evidence summary below (<a class="figpopup" href="/books/NBK581143/table/niceng217er9.tab3/?report=objectonly" target="object" rid-figpopup="figniceng217er9tab3" rid-ob="figobniceng217er9tab3">Table 3</a>).</p><p>See also the study selection flow chart in <a href="#niceng217er9.appc">Appendix C</a>: section <a href="#niceng217er9.appc.s1">C.1</a>, study evidence tables in <a href="#niceng217er9.appd">Appendix D</a>: section <a href="#niceng217er9.appd.s1">D.1</a>, forest plots in <a href="#niceng217er9.appe">Appendix E</a>: section <a href="#niceng217er9.appe.s1">E.1</a>, and GRADE tables in <a href="#niceng217er9.appf">Appendix F</a>: section <a href="#niceng217er9.appf.s1">F.1</a>.</p></div><div id="niceng217er9.s1.2.3.2"><h5>1.2.3.2. Excluded studies</h5><p>See the excluded studies list in <a href="#niceng217er9.appi">Appendix I</a>:.</p></div></div><div id="niceng217er9.s1.2.4"><h4>1.2.4. Summary of clinical studies included in the evidence review</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab2"><a href="/books/NBK581143/table/niceng217er9.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab2" rid-ob="figobniceng217er9tab2"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab2/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab2/?report=previmg" alt="Table 2. Summary of studies included in the evidence review." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab2"><a href="/books/NBK581143/table/niceng217er9.tab2/?report=objectonly" target="object" rid-ob="figobniceng217er9tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the evidence review. </p></div></div><p>See <a href="#niceng217er9.appd">Appendix D</a>: section <a href="#niceng217er9.appd.s1">D.1</a> for full evidence tables.</p></div><div id="niceng217er9.s1.2.5"><h4>1.2.5. Quality assessment of clinical studies included in the evidence review</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab3"><a href="/books/NBK581143/table/niceng217er9.tab3/?report=objectonly" target="object" title="Table 3" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab3" rid-ob="figobniceng217er9tab3"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab3/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab3/?report=previmg" alt="Table 3. Clinical evidence summary: Diazepam versus placebo." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab3"><a href="/books/NBK581143/table/niceng217er9.tab3/?report=objectonly" target="object" rid-ob="figobniceng217er9tab3">Table 3</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Diazepam versus placebo. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab4"><a href="/books/NBK581143/table/niceng217er9.tab4/?report=objectonly" target="object" title="Table 4" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab4" rid-ob="figobniceng217er9tab4"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab4/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab4/?report=previmg" alt="Table 4. Clinical evidence summary: Diazepam versus drugs (lorazepam, or midazolam)." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab4"><a href="/books/NBK581143/table/niceng217er9.tab4/?report=objectonly" target="object" rid-ob="figobniceng217er9tab4">Table 4</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Diazepam versus drugs (lorazepam, or midazolam). </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab5"><a href="/books/NBK581143/table/niceng217er9.tab5/?report=objectonly" target="object" title="Table 5" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab5" rid-ob="figobniceng217er9tab5"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab5/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab5/?report=previmg" alt="Table 5. Clinical evidence summary: Lorazepam versus placebo." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab5"><a href="/books/NBK581143/table/niceng217er9.tab5/?report=objectonly" target="object" rid-ob="figobniceng217er9tab5">Table 5</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Lorazepam versus placebo. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab6"><a href="/books/NBK581143/table/niceng217er9.tab6/?report=objectonly" target="object" title="Table 6" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab6" rid-ob="figobniceng217er9tab6"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab6/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab6/?report=previmg" alt="Table 6. Clinical evidence summary: Lorazepam versus drugs (diazepam, levetiracetam, paraldehyde, phenobarbital or phenytoin)." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab6"><a href="/books/NBK581143/table/niceng217er9.tab6/?report=objectonly" target="object" rid-ob="figobniceng217er9tab6">Table 6</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Lorazepam versus drugs (diazepam, levetiracetam, paraldehyde, phenobarbital or phenytoin). </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab7"><a href="/books/NBK581143/table/niceng217er9.tab7/?report=objectonly" target="object" title="Table 7" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab7" rid-ob="figobniceng217er9tab7"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab7/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab7/?report=previmg" alt="Table 7. Clinical evidence summary: Valproate versus phenytoin." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab7"><a href="/books/NBK581143/table/niceng217er9.tab7/?report=objectonly" target="object" rid-ob="figobniceng217er9tab7">Table 7</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Valproate versus phenytoin. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab8"><a href="/books/NBK581143/table/niceng217er9.tab8/?report=objectonly" target="object" title="Table 8" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab8" rid-ob="figobniceng217er9tab8"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab8/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab8/?report=previmg" alt="Table 8. Clinical evidence summary: Phenytoin versus phenobarbital." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab8"><a href="/books/NBK581143/table/niceng217er9.tab8/?report=objectonly" target="object" rid-ob="figobniceng217er9tab8">Table 8</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Phenytoin versus phenobarbital. </p></div></div><p>See <a href="#niceng217er9.appf">Appendix F</a>: section <a href="#niceng217er9.appf.s1">F.1</a> for full GRADE tables.</p></div><div id="niceng217er9.s1.2.6"><h4>1.2.6. Economic evidence</h4><div id="niceng217er9.s1.2.6.1"><h5>1.2.6.1. Included studies</h5><p>Two health economic studies with relevant comparisons were included in this review: Both were different country perspectives comparing the branded buccal Midazolam product of Buccolam, with standard care (can vary depending on perspective), another buccal midazolam product, and rectal diazepam.<a class="bibr" href="#niceng217er9.ref91" rid="niceng217er9.ref91"><sup>91</sup></a><sup>,</sup><a class="bibr" href="#niceng217er9.ref92" rid="niceng217er9.ref92"><sup>92</sup></a></p><p>These are summarised in the health economic evidence profiles below (<a class="figpopup" href="/books/NBK581143/table/niceng217er9.tab9/?report=objectonly" target="object" rid-figpopup="figniceng217er9tab9" rid-ob="figobniceng217er9tab9">Table 9</a> and <a class="figpopup" href="/books/NBK581143/table/niceng217er9.tab10/?report=objectonly" target="object" rid-figpopup="figniceng217er9tab10" rid-ob="figobniceng217er9tab10">Table 10</a>) and the health economic evidence tables in <a href="#niceng217er9.apph">Appendix H</a>: section <a href="#niceng217er9.apph.s1">H.1</a>.</p></div><div id="niceng217er9.s1.2.6.2"><h5>1.2.6.2. Excluded studies</h5><p>One economic study relating to this review question was identified but was excluded due to not being the correct economic evaluation design.<a class="bibr" href="#niceng217er9.ref19" rid="niceng217er9.ref19"><sup>19</sup></a> This is listed in <a href="#niceng217er9.appi">Appendix I</a>:, with reasons for exclusion given.</p><p>See also the health economic study selection flow chart in <a href="#niceng217er9.appg">Appendix G</a>: section <a href="#niceng217er9.appg.s1">G.1</a>.</p></div><div id="niceng217er9.s1.2.6.3"><h5>1.2.6.3. Summary of studies included in the economic evidence review</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab9"><a href="/books/NBK581143/table/niceng217er9.tab9/?report=objectonly" target="object" title="Table 9" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab9" rid-ob="figobniceng217er9tab9"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab9/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab9/?report=previmg" alt="Table 9. Health economic evidence profile: Buccolam versus standard care, buccal midazolam, and rectal diazepam." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab9"><a href="/books/NBK581143/table/niceng217er9.tab9/?report=objectonly" target="object" rid-ob="figobniceng217er9tab9">Table 9</a></h4><p class="float-caption no_bottom_margin">Health economic evidence profile: Buccolam versus standard care, buccal midazolam, and rectal diazepam. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab10"><a href="/books/NBK581143/table/niceng217er9.tab10/?report=objectonly" target="object" title="Table 10" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab10" rid-ob="figobniceng217er9tab10"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab10/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab10/?report=previmg" alt="Table 10. Health economic evidence profile: Buccolam versus standard care, buccal midazolam, and rectal diazepam." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab10"><a href="/books/NBK581143/table/niceng217er9.tab10/?report=objectonly" target="object" rid-ob="figobniceng217er9tab10">Table 10</a></h4><p class="float-caption no_bottom_margin">Health economic evidence profile: Buccolam versus standard care, buccal midazolam, and rectal diazepam. </p></div></div></div></div><div id="niceng217er9.s1.2.7"><h4>1.2.7. Economic model</h4><p>This area was not prioritised for new cost-effectiveness analysis.</p></div><div id="niceng217er9.s1.2.8"><h4>1.2.8. Unit costs</h4><p>Relevant unit costs are provided below to aid consideration of cost effectiveness. The most commonly used drugs reported in the included clinical evidence are reported here for an illustration of unit costs.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab11"><a href="/books/NBK581143/table/niceng217er9.tab11/?report=objectonly" target="object" title="Table 11" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab11" rid-ob="figobniceng217er9tab11"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab11/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab11/?report=previmg" alt="Table 11. UK costs of drugs used for Status Epilepticus." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab11"><a href="/books/NBK581143/table/niceng217er9.tab11/?report=objectonly" target="object" rid-ob="figobniceng217er9tab11">Table 11</a></h4><p class="float-caption no_bottom_margin">UK costs of drugs used for Status Epilepticus. </p></div></div><p>Some types of administration may also require other resources like an IV line and solution to dilute the drug for infusion.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab12"><a href="/books/NBK581143/table/niceng217er9.tab12/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab12" rid-ob="figobniceng217er9tab12"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab12/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab12/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab12"><a href="/books/NBK581143/table/niceng217er9.tab12/?report=objectonly" target="object" rid-ob="figobniceng217er9tab12">Table</a></h4></div></div></div><div id="niceng217er9.s1.2.9"><h4>1.2.9. Evidence statements</h4><div id="niceng217er9.s1.2.9.1"><h5>1.2.9.1. Effectiveness/Qualitative</h5><ul><li class="half_rhythm"><div>None</div></li></ul></div><div id="niceng217er9.s1.2.9.2"><h5>1.2.9.2. Economic</h5><ul><li class="half_rhythm"><div>Two cost utility analyses found that Buccolam was dominant (less costly and more effective) compared to standard care, buccal midazolam, and rectal diazepam. This analysis was assessed as partially applicable with potentially serious limitations.</div></li></ul></div></div></div><div id="niceng217er9.s1.3"><h3>1.3. Review question: Add on</h3><p>What antiepileptic drugs (add-on therapy) are effective in the treatment of status epilepticus?</p><div id="niceng217er9.s1.3.1"><h4>1.3.1. Summary of the protocol</h4><p>For full details, see the review protocol in <a href="#niceng217er9.appa">Appendix A</a>: section <a href="#niceng217er9.appa.s2">A.2</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab13"><a href="/books/NBK581143/table/niceng217er9.tab13/?report=objectonly" target="object" title="Table 12" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab13" rid-ob="figobniceng217er9tab13"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab13/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab13/?report=previmg" alt="Table 12. PICO characteristics of review question." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab13"><a href="/books/NBK581143/table/niceng217er9.tab13/?report=objectonly" target="object" rid-ob="figobniceng217er9tab13">Table 12</a></h4><p class="float-caption no_bottom_margin">PICO characteristics of review question. </p></div></div></div><div id="niceng217er9.s1.3.2"><h4>1.3.2. Methods and process</h4><p>This evidence review was developed using the methods and process described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. Methods specific to this review question are described in the review protocol in <a href="#niceng217er9.appa">appendix A</a> and the <a href="/books/NBK581143/bin/niceng217er9_bm1.pdf">methods</a> document.</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng217er9.s1.3.3"><h4>1.3.3. Effectiveness evidence</h4><div id="niceng217er9.s1.3.3.1"><h5>1.3.3.1. Included studies</h5><p>Twenty one studies and three supplemental studies (that report from the same trials) were included in the review;<a class="bibr" href="#niceng217er9.ref4" rid="niceng217er9.ref4"><sup>4</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref8" rid="niceng217er9.ref8"><sup>8</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref37" rid="niceng217er9.ref37"><sup>37</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref42" rid="niceng217er9.ref42"><sup>42</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref43" rid="niceng217er9.ref43"><sup>43</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref46" rid="niceng217er9.ref46"><sup>46</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref47" rid="niceng217er9.ref47"><sup>47</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref55" rid="niceng217er9.ref55"><sup>55</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref63" rid="niceng217er9.ref63"><sup>63</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref65" rid="niceng217er9.ref65"><sup>65</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref75" rid="niceng217er9.ref75"><sup>75</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref106" rid="niceng217er9.ref106"><sup>106</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref107" rid="niceng217er9.ref107"><sup>107</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref111" rid="niceng217er9.ref111"><sup>111</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref113" rid="niceng217er9.ref113"><sup>113</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref120" rid="niceng217er9.ref120"><sup>120</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref122" rid="niceng217er9.ref122"><sup>122</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref144" rid="niceng217er9.ref144"><sup>144</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref179" rid="niceng217er9.ref179"><sup>179</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref192" rid="niceng217er9.ref192"><sup>192</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref205" rid="niceng217er9.ref205"><sup>205</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref233" rid="niceng217er9.ref233"><sup>233</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng217er9.ref238" rid="niceng217er9.ref238"><sup>238</sup></a> these are summarised in <a class="figpopup" href="/books/NBK581143/table/niceng217er9.tab2/?report=objectonly" target="object" rid-figpopup="figniceng217er9tab2" rid-ob="figobniceng217er9tab2">Table 2</a>. Studies were identified in both children and adult populations. Subgroup analysis by age was only conducted where there was evidence of heterogeneity. This occurred for one outcome comparing sodium valproate and phenobarbital<a class="bibr" href="#niceng217er9.ref111" rid="niceng217er9.ref111"><sup>111</sup></a><sup>,</sup><a class="bibr" href="#niceng217er9.ref205" rid="niceng217er9.ref205"><sup>205</sup></a>Evidence from these studies is summarised in the clinical evidence summary below (<a class="figpopup" href="/books/NBK581143/table/niceng217er9.tab3/?report=objectonly" target="object" rid-figpopup="figniceng217er9tab3" rid-ob="figobniceng217er9tab3">Table 3</a>). All studies were on convulsive status epilepticus (SE). They were all in epilepsy populations that had previously failed to stabilise on a benzodiazepine. The majority of the studies were conducted in the emergency department (ED)</p><p>See also the study selection flow chart in <a href="#niceng217er9.appc">Appendix C</a>: section <a href="#niceng217er9.appc.s2">C.2</a> study evidence tables in <a href="#niceng217er9.appd">Appendix D</a>: section <a href="#niceng217er9.appd.s2">D.2</a>, forest plots in <a href="#niceng217er9.appe">Appendix E</a>: section <a href="#niceng217er9.appe.s2">E.2</a> and GRADE tables in <a href="#niceng217er9.appf">Appendix F</a>: section <a href="#niceng217er9.appf.s2">F.2</a>.</p></div><div id="niceng217er9.s1.3.3.2"><h5>1.3.3.2. Excluded studies</h5><p>See the excluded studies list in <a href="#niceng217er9.appi">Appendix I</a>:</p></div></div><div id="niceng217er9.s1.3.4"><h4>1.3.4. Summary of clinical studies included in the evidence review</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab14"><a href="/books/NBK581143/table/niceng217er9.tab14/?report=objectonly" target="object" title="Table 13" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab14" rid-ob="figobniceng217er9tab14"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab14/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab14/?report=previmg" alt="Table 13. Summary of studies included in the evidence review." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab14"><a href="/books/NBK581143/table/niceng217er9.tab14/?report=objectonly" target="object" rid-ob="figobniceng217er9tab14">Table 13</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the evidence review. </p></div></div><p>See <a href="#niceng217er9.appd">Appendix D</a>: section <a href="#niceng217er9.appd.s2">D.2</a> for full evidence tables.</p></div><div id="niceng217er9.s1.3.5"><h4>1.3.5. Quality assessment of clinical studies included in the evidence review</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab15"><a href="/books/NBK581143/table/niceng217er9.tab15/?report=objectonly" target="object" title="Table 14" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab15" rid-ob="figobniceng217er9tab15"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab15/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab15/?report=previmg" alt="Table 14. Clinical evidence summary: Sodium valproate versus phenytoin." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab15"><a href="/books/NBK581143/table/niceng217er9.tab15/?report=objectonly" target="object" rid-ob="figobniceng217er9tab15">Table 14</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Sodium valproate versus phenytoin. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab16"><a href="/books/NBK581143/table/niceng217er9.tab16/?report=objectonly" target="object" title="Table 15" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab16" rid-ob="figobniceng217er9tab16"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab16/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab16/?report=previmg" alt="Table 15. Clinical evidence summary: Levetiracetam versus phenytoin." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab16"><a href="/books/NBK581143/table/niceng217er9.tab16/?report=objectonly" target="object" rid-ob="figobniceng217er9tab16">Table 15</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Levetiracetam versus phenytoin. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab17"><a href="/books/NBK581143/table/niceng217er9.tab17/?report=objectonly" target="object" title="Table 16" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab17" rid-ob="figobniceng217er9tab17"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab17/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab17/?report=previmg" alt="Table 16. Clinical evidence summary: Lignocaine versus midazolam." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab17"><a href="/books/NBK581143/table/niceng217er9.tab17/?report=objectonly" target="object" rid-ob="figobniceng217er9tab17">Table 16</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Lignocaine versus midazolam. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab18"><a href="/books/NBK581143/table/niceng217er9.tab18/?report=objectonly" target="object" title="Table 17" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab18" rid-ob="figobniceng217er9tab18"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab18/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab18/?report=previmg" alt="Table 17. Clinical evidence summary: Sodium valproate versus lacosamide." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab18"><a href="/books/NBK581143/table/niceng217er9.tab18/?report=objectonly" target="object" rid-ob="figobniceng217er9tab18">Table 17</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Sodium valproate versus lacosamide. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab19"><a href="/books/NBK581143/table/niceng217er9.tab19/?report=objectonly" target="object" title="Table 18" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab19" rid-ob="figobniceng217er9tab19"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab19/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab19/?report=previmg" alt="Table 18. Clinical evidence summary: Midazolam versus diazepam." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab19"><a href="/books/NBK581143/table/niceng217er9.tab19/?report=objectonly" target="object" rid-ob="figobniceng217er9tab19">Table 18</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Midazolam versus diazepam. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab20"><a href="/books/NBK581143/table/niceng217er9.tab20/?report=objectonly" target="object" title="Table 19" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab20" rid-ob="figobniceng217er9tab20"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab20/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab20/?report=previmg" alt="Table 19. Clinical evidence summary: Propofol versus midazolam." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab20"><a href="/books/NBK581143/table/niceng217er9.tab20/?report=objectonly" target="object" rid-ob="figobniceng217er9tab20">Table 19</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Propofol versus midazolam. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab21"><a href="/books/NBK581143/table/niceng217er9.tab21/?report=objectonly" target="object" title="Table 20" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab21" rid-ob="figobniceng217er9tab21"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab21/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab21/?report=previmg" alt="Table 20. Clinical evidence summary: Phenobarbital versus sodium valproate." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab21"><a href="/books/NBK581143/table/niceng217er9.tab21/?report=objectonly" target="object" rid-ob="figobniceng217er9tab21">Table 20</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Phenobarbital versus sodium valproate. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab22"><a href="/books/NBK581143/table/niceng217er9.tab22/?report=objectonly" target="object" title="Table 21" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab22" rid-ob="figobniceng217er9tab22"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab22/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab22/?report=previmg" alt="Table 21. Clinical evidence summary: Sodium valproate versus diazepam." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab22"><a href="/books/NBK581143/table/niceng217er9.tab22/?report=objectonly" target="object" rid-ob="figobniceng217er9tab22">Table 21</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Sodium valproate versus diazepam. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab23"><a href="/books/NBK581143/table/niceng217er9.tab23/?report=objectonly" target="object" title="Table 22" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab23" rid-ob="figobniceng217er9tab23"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab23/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab23/?report=previmg" alt="Table 22. Clinical evidence summary: Levetiracetam versus Fosphenytoin." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab23"><a href="/books/NBK581143/table/niceng217er9.tab23/?report=objectonly" target="object" rid-ob="figobniceng217er9tab23">Table 22</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Levetiracetam versus Fosphenytoin. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab24"><a href="/books/NBK581143/table/niceng217er9.tab24/?report=objectonly" target="object" title="Table 23" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab24" rid-ob="figobniceng217er9tab24"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab24/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab24/?report=previmg" alt="Table 23. Clinical evidence summary: Levetiracetam versus valproate." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab24"><a href="/books/NBK581143/table/niceng217er9.tab24/?report=objectonly" target="object" rid-ob="figobniceng217er9tab24">Table 23</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Levetiracetam versus valproate. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab25"><a href="/books/NBK581143/table/niceng217er9.tab25/?report=objectonly" target="object" title="Table 24" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab25" rid-ob="figobniceng217er9tab25"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab25/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab25/?report=previmg" alt="Table 24. Clinical evidence summary: Fosphenytoin versus valproate." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab25"><a href="/books/NBK581143/table/niceng217er9.tab25/?report=objectonly" target="object" rid-ob="figobniceng217er9tab25">Table 24</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Fosphenytoin versus valproate. </p></div></div><p>See <a href="#niceng217er9.appf">Appendix F</a>: section for full GRADE tables.</p></div><div id="niceng217er9.s1.3.6"><h4>1.3.6. Economic evidence</h4><div id="niceng217er9.s1.3.6.1"><h5>1.3.6.1. Included studies</h5><p>No health economic studies were included.</p></div><div id="niceng217er9.s1.3.6.2"><h5>1.3.6.2. Excluded studies</h5><p>No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.</p><p>See also the health economic study selection flow chart in <a href="#niceng217er9.appg">Appendix G</a>: Section <a href="#niceng217er9.appg.s2">G.2</a>.</p></div></div><div id="niceng217er9.s1.3.7"><h4>1.3.7. Economic model</h4><p>This area was not prioritised for a new cost-effectiveness analysis.</p></div><div id="niceng217er9.s1.3.8"><h4>1.3.8. Unit costs</h4><p>Relevant unit costs are provided below to aid consideration of cost-effectiveness. The most commonly used drugs reported in the included clinical evidence are reported here for an illustration of unit costs.</p><p>Other resources may be required like an IV line and solution to dilute the drug for infusion.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng217er9tab26"><a href="/books/NBK581143/table/niceng217er9.tab26/?report=objectonly" target="object" title="Table 25" class="img_link icnblk_img figpopup" rid-figpopup="figniceng217er9tab26" rid-ob="figobniceng217er9tab26"><img class="small-thumb" src="/books/NBK581143/table/niceng217er9.tab26/?report=thumb" src-large="/books/NBK581143/table/niceng217er9.tab26/?report=previmg" alt="Table 25. UK costs of drugs used as add on therapy for Status Epilepticus." /></a><div class="icnblk_cntnt"><h4 id="niceng217er9.tab26"><a href="/books/NBK581143/table/niceng217er9.tab26/?report=objectonly" target="object" rid-ob="figobniceng217er9tab26">Table 25</a></h4><p class="float-caption no_bottom_margin">UK costs of drugs used as add on therapy for Status Epilepticus. </p></div></div></div><div id="niceng217er9.s1.3.9"><h4>1.3.9. Evidence statements</h4><div id="niceng217er9.s1.3.9.1"><h5>1.3.9.1. Effectiveness/Qualitative</h5><ul><li class="half_rhythm"><div>None.</div></li></ul></div><div id="niceng217er9.s1.3.9.2"><h5>1.3.9.2. Economic</h5><ul><li class="half_rhythm"><div>No relevant economic evaluations were identified.</div></li></ul></div></div></div><div id="niceng217er9.s1.4"><h3>1.4. The committee’s discussion of the evidence</h3><div id="niceng217er9.s1.4.1"><h4>1.4.1. Interpreting the evidence</h4><div id="niceng217er9.s1.4.1.1"><h5>1.4.1.1. The outcomes that matter most</h5><p>All outcomes included in these reviews were considered to be critical outcomes. These included time to seizure cessation, quality of life, and healthcare resource use. The following outcomes were considered harms; mortality, seizure recurrence, length of hospital stay, ICU admission, length of ICU stay and adverse events of respiratory depression, hypotension, frequency of endotracheal intubation, and neuropsychological events such as confusion, anxiety, challenging behaviour and mood disturbance. The status epilepticus reviews also included the critical outcomes of seizure recurrence within less than 24 hours of initial treatment (harm) and mean Glasgow Outcome Scale.</p></div><div id="niceng217er9.s1.4.1.2"><h5>1.4.1.2. The quality of the evidence</h5><div id="niceng217er9.s1.4.1.2.1"><h5>AED monotherapy for status epilepticus</h5><p>The quality of the evidence ranged from high to very low quality. Evidence was evenly distributed in either the moderate-, low- or very low categories. Studies were downgraded due to lack of allocation concealment or imprecision or both.</p></div><div id="niceng217er9.s1.4.1.2.2"><h5>AED add-on treatment for status epilepticus</h5><p>The quality of the evidence ranged from high to very low quality. Most of the evidence was of very low quality. Studies were downgraded due to lack of allocation concealment or imprecision or both.</p></div><div id="niceng217er9.s1.4.1.2.3"><h5>AED monotherapy for repeated or clusters of seizures</h5><p>Two studies were included with the quality of evidence consisting of moderate, low and very low quality for the three included outcomes. Studies were downgraded due to lack of allocation concealment or imprecision or both.</p></div><div id="niceng217er9.s1.4.1.2.4"><h5>AED add-on treatment for repeated or clusters of seizures</h5><p>Two studies were included with the quality of evidence being of either moderate or low quality. Studies were downgraded due to lack of allocation concealment or imprecision or both.</p></div><div id="niceng217er9.s1.4.1.2.5"><h5>AED monotherapy and add-on treatment for prolonged seizures</h5><p>No evidence was found for AED treatments for prolonged seizures</p></div></div><div id="niceng217er9.s1.4.1.3"><h5>1.4.1.3. Benefits and harms</h5><div id="niceng217er9.s1.4.1.3.1"><h5>AED monotherapy for status epilepticus</h5><p>The evidence was from 20 randomised controlled trials assessing convulsive status epilepticus (SE), with 2 studies including adults only and 2 studies including a mixed population of adults and children, and the remaining 16 trials included children only. The studies available evaluated diazepam, lorazepam, midazolam, levetiracetam, paraldehyde, phenobarbital, phenytoin and valproate. Evidence was found for the following comparisons (note some studies examined more than 1 comparison):
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<ul><li class="half_rhythm"><div>diazepam versus placebo (1 study)</div></li><li class="half_rhythm"><div>diazepam versus lorazepam (3 studies)</div></li><li class="half_rhythm"><div>diazepam versus midazolam (10 studies)</div></li><li class="half_rhythm"><div>lorazepam versus placebo (1 study)</div></li><li class="half_rhythm"><div>lorazepam versus levetiracetam (1 study)</div></li><li class="half_rhythm"><div>lorazepam versus paraldehyde (1 study)</div></li><li class="half_rhythm"><div>lorazepam versus phenobarbital (1 study)</div></li><li class="half_rhythm"><div>lorazepam versus or phenytoin (1 study)</div></li><li class="half_rhythm"><div>valproate versus phenytoin (1 study)</div></li><li class="half_rhythm"><div>phenytoin versus phenobarbital (1 study)</div></li></ul></p><p>The evidence showed a clinically important benefit for diazepam compared with placebo for termination of SE at time of arrival at ED, and a trend for an overall clinically important benefit for mortality, termination of seizures within 10 minutes and seizure recurrence within 24 hours. With the exception of mortality, no evidence was found for the other harm outcomes.</p><p>There was a trend for a clinically important benefit for diazepam compared with lorazepam for the termination of SE at time of arrival at ED. There was a clinically important benefit for diazepam compared with lorazepam for termination of SE within 5 minutes while in contrast there was a clinically important benefit for midazolam compared with diazepam for this outcome. There was a trend for a clinically important benefit for midazolam compared with diazepam for the outcome of termination of seizure within 10 minutes. Diazepam and lorazepam were clinically equivalent for this outcome. There was a clinically important benefit for diazepam compared with lorazepam for the outcome of termination of seizure within 20 minutes. Time to seizure cessation was equivalent for diazepam and lorazepam, as was time to cessation after drug administration for diazepam and midazolam. In terms of harms, there was no evidence of a clinically important difference for diazepam compared with lorazepam and midazolam for the outcome of mortality. There was a trend for a clinically important benefit of midazolam compared with diazepam for harm outcome of seizure recurrence within 24 hours, while lorazepam and diazepam were equivalent. There was a trend for a clinically important benefit for diazepam compared with midazolam for the adverse event of respiratory depression while no evidence of benefit for diazepam compared with lorazepam for respiratory depression. The only other harm was hypotension, and there was a trend for a clinically important benefit for diazepam compared with midazolam.</p><p>The evidence showed a clinically important benefit for lorazepam compared with placebo for termination of SE at time of arrival at ED, and a trend overall clinically important benefit for mortality.</p><p>There was no evidence of the benefit of lorazepam compared with diazepam and paraldehyde for termination of SE within 10 minutes. There was a clinically important benefit of lorazepam compared with diazepam for termination of SE at time of arrival at ED, while, conversely, there was clinical benefit for midazolam versus lorazepam for this outcome. Termination of SE within 30 minutes for lorazepam and levetiracetam was clinically equivalent as was time to seizure cessation for lorazepam compared with midazolam. For the outcomes of harms, there was no evidence of clinically important benefit for lorazepam for mortality compared with diazepam, levetiracetam or paraldehyde. There was no clinically important benefit of lorazepam compared with diazepam, levetiracetam, midazolam or paraldehyde for the outcome of seizure recurrence within 24 hours. There was a trend for a clinically important benefit for midazolam compared with lorazepam for length of hospital stay, while in contrast there was trend for a clinical benefit for lorazepam compared with midazolam for the outcome of length of ICU stay. There was a trend for a clinical benefit of levetiracetam compared with lorazepam for the adverse events outcomes of respiratory failure and hypotension. Hypotension was equivalent for lorazepam compared with diazepam, midazolam, phenobarbital and phenytoin.</p><p>There was a clinically important benefit - for valproate for termination of SE after drug infusion compared with phenytoin. Seizure freedom at 24 hours was equivalent for the two drugs. There was a clinically important benefit for valproate compared with phenytoin for the harm outcome of seizure recurrence within 24 hours. There was a clinically important benefit for phenytoin versus phenobarbital for the adverse event of hypotension.</p><p>The committee considered there was no clear evidence to support one drug over another but agreed that valproate is not generally used historically in the UK as the first-line option. The evidence demonstrated that the benefit of all AEDs outweighed the harms. Although much of the evidence found was in children, it was thought appropriate to make recommendations for all populations as treatment decisions are considered similar for both adults and children. This was based on the experience and expertise of the committee.</p><p>The committee agreed to recommend benzodiazepines as first-line option for immediate use for SE, reflecting the evidence and current standard clinical practice. The committee acknowledged it was important to consider the setting when recommending which route of administration. Intravenous lorazepam is routinely given in hospitals, and it is rapid in action. The committee’s experience was that lorazepam causes less respiratory depression and sedation relative to other drugs. The committee agreed that intravenous lorazepam should be given as first-line treatment option if intravenous access and resuscitation facilities were readily available.</p><p>The committee acknowledged intravenous access would not be readily available in the community. Buccal midazolam is more commonly used in community settings, and based on their experience and the evidence, the committee agreed that it should remain as the first choice, with rectal diazepam as an alternative if agreed based on previous use or if buccal midazolam is unavailable. The committee discussed that the rectal route of administration is the least preferred and not routinely chosen. The importance of having a tailored and individualised patient emergency management plan was discussed, and it was agreed that the administration of any drugs by trained community caregivers should be detailed within the patient’s individual managementplan.</p><p>The committee discussed how the speed of delivery could be more important than the benzodiazepine administered, as it is imperative a suitable drug is given as soon as possible to stop the seizure and aid recovery. If SE has not stopped within 5 minutes of administration of a first dose of benzodiazepine, a second dose would be given as standard practice.</p><p>The committee noted no evidence was found for non-convulsive seizures but suggested that a benzodiazepine would also be the first-line option for this population.</p></div><div id="niceng217er9.s1.4.1.3.2"><h5>AED add-on therapies for status epilepticus when first-line treatment has failed</h5><p>The evidence was from 21 randomised controlled trials assessing SE after failure on one AED, with 9 studies assessing adults, 11 assessing children and 1 assessing a mixture of adults and children. Participants had not responded to benzodiazepines. The comparisons included the following drugs when first-line therapy had failed:
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<ul><li class="half_rhythm"><div>sodium valproate versus phenytoin (4 studies)</div></li><li class="half_rhythm"><div>sodium valproate versus phenobarbital (2 studies)</div></li><li class="half_rhythm"><div>levetiracetam versus phenytoin (7 studies)</div></li><li class="half_rhythm"><div>levetiracetam versus sodium valproate (1 study)</div></li><li class="half_rhythm"><div>lignocaine versus midazolam (1 study)</div></li><li class="half_rhythm"><div>sodium valproate versus lacosamide (1 study)</div></li><li class="half_rhythm"><div>midazolam versus diazepam (1 study)</div></li><li class="half_rhythm"><div>propofol versus midazolam (1 study)</div></li><li class="half_rhythm"><div>sodium valproate versus diazepam (2 studies)</div></li><li class="half_rhythm"><div>levetiracetam versus fosphenytoin (3 studies)</div></li></ul></p><p>The majority of the studies evaluated AEDs administered intravenously.</p><p>There was a trend for a clinical benefit of sodium valproate compared with phenytoin for the outcomes of cessation of SE within 20 minutes, cessation of SE within 12 hours and cessation of SE within 7 days. Evidence for harms showed a trend for clinical benefit of sodium valproate for seizure recurrence within 24 hours. There was clinical benefit for valproate compared with phenytoin for the adverse events of respiratory depression and hypotension.</p><p>There was a trend for a clinical benefit of levetiracetam compared with phenytoin for the outcomes of cessation of seizure within 5 minutes, cessation of seizure within 30 minutes and cessation of SE within 24 hours. There was no evidence of benefit of levetiracetam compared with phenytoin for cessation of SE within 2 hours. Mean duration of SE in good responders was equivalent for the two drugs, as was good outcome at discharge according to the Functional Independence Measure (FIM). Phenytoin showed a trend for a clinical benefit for good outcome at discharge according to the mRS score. In terms of harms, there was a trend for a clinical benefit of levetiracetam compared with phenytoin for the outcome of mortality. There was a trend for a clinical benefit of levetiracetam versus phenytoin for recurrence of seizures within 24 hours. The evidence showed equivalence for the harm outcome of hypertension. - Phenytoin showed a trend for a clinically important difference for the harms of length of hospital stay, admission to critical care and confusion compared with levetiracetam.</p><p>Lignocaine showed clinically important benefit compared with midazolam for the outcomes of cessation of SE, length of ICU stays and intubation needing mechanical intubation.</p><p>There was a trend for a clinical benefit of valproate compared with lacosamide for the outcome of time for seizure cessation after drug administration and seizure freedom within 24 hours. There was clinical equivalence for cessation of SE for 1 hour. Considering harms, there was a trend for a clinical benefit of lacosamide compared with valproate for the outcome of mortality, while for hypotension, clinical equivalence was found.</p><p>There was a trend for a clinically importance benefit of diazepam compared with midazolam for the outcomes of, time to final seizure and seizure recurrence whilst on infusion. Diazepam and midazolam showed clinical equivalence for time to initial seizure cessation, cessation of SE within 6 hours. In terms of harms there was a trend for a clinically importance benefit of diazepam compared with midazolam and a clinically important difference for seizure recurrence after stopping infusion. Diazepam and midazolam showed clinical equivalence for hypotension.</p><p>There was a trend for a clinically important benefit of midazolam compared with propofol for the harm outcomes of mortality and hypotension. There was a trend for an evidence of benefit of propofol compared with midazolam for cessation of SE for 48 hours.</p><p>Phenobarbital showed a trend for a clinically important benefit compared with valproate for the harm outcomes of mortality and for hypotension. Valproate showed trend for a clinically important benefit compared with phenobarbital for seizure cessation within 20 minutes and clinically important benefit for the harm outcome of transient depressed respiration. In children, there was a clinically important benefit of valproate compared with phenobarbital for recurrence of seizure within 24 hours, while in adults, the converse was true.</p><p>Valproate and diazepam showed clinical equivalence for the outcome of cessation of SE within 30 minutes and 1 hour. there was clinical equivalence for the two drugs. There was a clinically important benefit of valproate compared with diazepam for time for seizure cessation after drug administration.</p><p>With respect to harms, diazepam showed a trend for a clinically important benefit compared with valproate for the outcome of mortality. Evidence showed that valproate had a clinically important benefit for ICU admission, hypotension and respiratory depression compared with diazepam. There was a trend for a benefit of valproate for seizure recurrence within 24 hours and need for intubation.</p><p>Evidence found that there was clinical equivalence for fosphenytoin and levetiracetam for the outcomes of cessation of SE within 5, 10 to 20, and 60 minutes. There was a trend for benefit of fosphenytoin for time to seizure cessation. Considering harms, fosphenytoin showed a trend for a clinically important benefit compared with levetiracetam for the outcome of mortality, while for seizure recurrence 24 hours and seizure recurrence within 48 hours there was clinical equivalence. There was clinical equivalence for fosphenytoin and levetiracetam for the following harm outcomes; ICU admission, length of hospital stay, length of PICU stay. There was a trend for evidence of benefit for levetiracetam compared with fosphenytoin for respiratory depression, hypotension. Clinical equivalence was found for bradycardia and the need for intubation.</p><p>There was clinical equivalence for valproate and levetiracetam drugs for the outcomes of cessation of SE within 60 minutes and seizure cessation within 24 hours. There was clinical equivalence for valproate compared with levetiracetam for the harm outcome of mortality. Evidence showed clinical equivalence for the other harmful outcomes of ICU admission, depression and hypotension.</p><p>Evidence showed clinical equivalence for valproate and fosphenytoin for the outcomes of cessation of SE within 60 minutes and seizure cessation within 24 hours and ICU admission. In terms of harms, valproate showed a trend for a clinically important benefit compared with fosphenytoin for the outcomes of mortality, respiratory depression and hypotension.</p><p>The committee agreed there was no evidence to support the selection of one of these drugs over another because of the overall clinical equivalence demonstrated in the studies. Therefore, any would be appropriate unless specific conditions mandated a restriction of choice (for example, previous allergic reaction to phenytoin). The committee, therefore, agreed to recommend one of levetiracetam, phenytoin or valproate as first-line add-on treatment. The committee discussed the importance of the choice being individualised and patient centred.</p><p>There were also two studies on general anaesthetics, with lignocaine and propofol, as well as phenobarbital showing clinical benefit for the outcomes of mortality, cessation of SE, seizure recurrence within 24 hours (adults), length of ICU stay, intubation need and the adverse event of hypotension. The committee decided to recommend the use of general anaesthetics or phenobarbital as third-line treatment options if the first- and second-line treatments were ineffective.</p><p>The committee discussed the importance of being aware of the different circumstances that could also cause SE, such as pregnancy, hypoglycaemia, alcohol withdrawal or autoimmune epilepsy where additional treatments may be required. The need to differentiate psychogenic non-epileptic seizures from seeming convulsive SE was also discussed.</p><p>The committee noted that there were two particularly significant trials included in the review. It was discussed how the ESETT trial showed results for fosfenytoin, levetiracetam and valproate that were overall equivalent and noted that this was a well conducted trial. The ECLIPSE trial showed phenytoin to be beneficial. The committee noted that these trials might encourage levetiracetam use owing to the ease of transitioning to longer term therapy with levetiracetam, perhaps particularly in women of child-bearing potential as levetiracetam has relatively low teratogenic potential. The GC noted that all the studies within this review were conducted in a hospital setting.</p></div><div id="niceng217er9.s1.4.1.3.3"><h5>AED monotherapy and add-on therapies for repeated seizures and clusters of seizures</h5><p>For monotherapy of repeated seizures or clusters of seizures, two small trials in adults and children comparing diazepam with placebo were included. A clinically important benefit was shown for diazepam for seizure freedom and patients requiring additional emergency treatment. A clinically important benefit for placebo was shown for harm outcomes of the nervous system including abnormal coordination, dizziness, euphoria, nervousness and somnolence.</p><p>For add-on therapy two comparisons were included, comparing levetiracetam with phenytoin and midazolam with diazepam. A clinically important benefit was shown for levetiracetam and diazepam overall.</p><p>The committee agreed that due to a lack of evidence, a research recommendation should be made. They noted that the definition of repeated/cluster seizures varies. Acute repetitive or cluster seizures are a medical emergency. The committee noted clobazam and midazolam often used in practice and made a consensus recommendation for their use.</p></div><div id="niceng217er9.s1.4.1.3.4"><h5>AED Monotherapy and add-on therapies for prolonged seizures</h5><p>No studies were found for prolonged seizures and the committee made consensus recommendations.</p><p>The committee defined prolonged seizures as seizures lasting more than 2 minutes above the typical duration of a person’s seizure, but less than 5 minutes. The committee noted that midazolam is often used and discussed that once an individualised patient management plan is in place, then this is a reasonable route to take. The committee noted that following a first episode of prolonged seizures in a person with a known diagnosis of epilepsy the person should be seen by a specialist. It is possible for further prolonged seizures to be managed in the community once a midazolam protocol is in place. This protocol will need to be regularly reviewed by an epilepsy nurse.</p><p>The committee agreed it was important for the recommendations to distinguish between convulsive and non-convulsive prolonged seizures to ensure emergency management plans are developed accordingly. They decided to make a consensus recommendation for an emergency plan to be developed for a person who has had a non-convulsive seizure that is 2 minutes longer than their usual seizure, if there is concern the seizure may recur.</p><p>No evidence was found for non-convulsive status epilepticus. The committee was unable to make general recommendations although the committee noted that benzodiazepines would usually be the first treatment of choice. The committee also noted that it was important not to over-sedate people in non-convulsive SE. This was because the risk of injury and mortality from non-convulsive SE is generally less than from convulsive SE. The committee noted that excessive sedation of patients could, for example, result in unnecessary intubation and other co-morbidities. The committee noted that people with non-convulsive epilepsy should have individualised and specialist advice. The committee agreed further research is needed and developed a research recommendation for this population.</p></div></div><div id="niceng217er9.s1.4.1.4"><h5>1.4.1.4. Cost effectiveness and resource use</h5><div id="niceng217er9.s1.4.1.4.1"><h5>AED monotherapy for status epilepticus</h5><p>Two economic evaluations were included for the status epilepticus monotherapy question. Both were from a UK NHS perspective (Lee 2013 was from Wales, and Lee 2014 was from Scotland), and decision analyses looking at the branded version of buccal midazolam (buccolam) compared to standard practice (as defined by clinicians), buccal midazolam (non Buccolam product) and rectal diazepam.</p><p>Lee 2013 defined standard practice for Wales as 95% buccal midazolam, and 5% rectal diazepam. The population was paediatric patients with a diagnosis of epilepsy suffering prolonged, acute, convulsive seizures in the community setting. The time horizon was 6 years. This was a probabilistic discrete event simulation and decision tree model based on a single UK RCT (McIntyre 2005). The discrete event simulation part of the model simulated 5000 patients for each treatment. For each of these patients, the frequency, location of seizures, and the initial store of drugs at each location were simulated at the start of the model. The availability of medication at each location was then adjusted by the occurrence of seizures within the model time horizon. If the model reached a point where drugs were disposed of due to expiry, then the value of the disposed products were calculated, and new products ordered. The decision tree part of the model calculated the likelihood of events once a seizure occurred, like whether medication was available, and if treatment was administered by parent/caregiver, and the probability of going to hospital. As the model was produced as a submission for a health technology appraisal for the approval of Buccolam, then the model is structured in a way that captures the benefit of the branded product, such as the fact that it comes packaged with 4 pre-filled syringes that can be split between locations. The study showed that Buccolam dominated all comparators. This was rated as partially applicable, because it was a UK study, but the EQ-5D was filled in by clinicians rather than patients or their parents/carers, which conflicts with the NICE reference case. The study was rated as having potentially serious limitations because the costs were out of date, as in the BNF there is only one product of buccal Midazolam that is not Buccolam. This is called Epistatus, and based on current BNF costs would be more expensive now because it only comes in one pre-filled syringe. However, costs depend on the dose and how it is packaged (separate pre-filled multiple syringes or not) so there is uncertainty about how the result of the study might be affected, as there are also generic versions of buccal midazolam available which are not listed in the BNF. There is also a conflict of interest because it is funded by the manufacturers of Buccolam, and most inputs were assumptions elicited from surveys of clinicians or parents.</p><p>Lee 2014 has the same structure as Lee 2013, and used the same trial for effectiveness data, but is from a Scottish perspective; therefore, some of the inputs are different because they were elicited from clinicians specific to Scotland. Standard care in this study was 100% buccal midazolam. The study had a 1-year time horizon. This also found that Buccolam dominated all comparators and was also rated as partially applicable with potentially serious limitations.</p><p>Buccal administrations tend to be more expensive than rectal or IV. However, as mentioned above, there is some uncertainty about prices and what can be acquired locally compared to the nationally available information.</p><p>The committee’s interpretation of the clinical evidence for this question, was that benzodiazepines are effective for the treatment of status epilepticus in a community setting, and it is difficult to distinguish within the class or between administration types. The committee drafted recommendations that they felt were in line with current practice, where buccal midazolam is used in the community. If IV access is available, then lorazepam was recommended as this is commonly used in a hospital setting for the treatment of status epilepticus.</p></div><div id="niceng217er9.s1.4.1.4.2"><h5>AED add-on treatment for status epilepticus</h5><p>No economic evidence was identified.</p><p>The clinical review showed that a variety of drugs had clinical benefit, such as sodium valproate, levetiracetam, and phenytoin. One of the studies included showed clinical equivalence between fosphenytoin, levetiracetam and valproate. While fosphenytoin was used in the trial, in the UK phenytoin is more commonly administered for SE. There are differences in costs between the different drugs, with sodium valproate and levetiracetam being more expensive. The committee decided to recommend that either levetiracetam, phenytoin or sodium valproate, as adjunctive treatments if seizures have continued after administration of benzodiazepines. Although some drugs might have higher costs, the committee explained that clinicians can prefer different drugs in different circumstances, for example, because, phenytoin requires cardiac monitoring during administration and because valproate should be avoided in people with underlying mitochondrial disorders’.</p><p>Recommendations were also made for third-line treatment based on committee consensus of current practice.</p></div><div id="niceng217er9.s1.4.1.4.3"><h5>AED monotherapy and add-on therapies for repeated seizures and clusters of seizures</h5><p>No economic evidence was identified for these questions. The committee made consensus recommendations and decided to make a research recommendation but noted that clobazam is typically used for repeated clusters and seizures.</p><p>The recommendations made are reflective of current practice and so are not expected result in a significant resource impact.</p></div><div id="niceng217er9.s1.4.1.4.4"><h5>AED Monotherapy and add-on therapies for prolonged seizures</h5><p>No economic evidence was identified for these questions. The committee wanted to make clear in a recommendation what the definition of a prolonged seizure is and how it should be treated immediately.</p><p>The committee agreed that all the recommendations made are likely to be in line with current practice.</p></div></div><div id="niceng217er9.s1.4.1.5"><h5>1.4.1.5. Other factors the committee took into account</h5><p>The committee discussed how the operational definitions of status epilepticus (SE) had changed recently. While it was previously held that a seizure had to persist for thirty minutes to be classified as SE, the International League Against Epilepsy (ILAE) have proposed a new definition of SE. According to the consensus statement (Trinka et al., 2015), two relevant time points are proposed. t1 is considered the point at which mechanisms to prevent abnormally prolonged seizures become ineffective. t2 is the point beyond which status epilepticus can cause, for example, loss or injury to nerve cells and changes to nerve cell networks.</p><p>This conceptual definition allows for t1 (after which seizure activity is thought continuous) and t2 (after which there is a risk of long-term consequences) to be different for different seizure types. For bilateral tonic clonic seizures, t1 is 5 minutes and t2 30 minutes.</p><p>The committee, therefore, defined SE for the purposes of all searches as seizures lasting 5 minutes or more. This was chosen to include more recent literature and also because setting a short time threshold would capture more papers.</p><div id="niceng217er9.s1.4.1.5.1"><h5>AED add-on treatment for status epilepticus</h5><p>The committee also acknowledged that in current clinical practice levetiracetam is more routinely used compared to phenytoin and valproate, mainly due to the ease of administration and efficacy.</p><p>However, the evidence has shown that they are all equally effective. Side effect profiles of each of the medications need to be taken into consideration and tailored for the person. This is particularly important for Phenytoin considering the risk of teratogenicity in women of childbearing age. It is also important to note that this advice is for use in emergency administration. Long term treatment needs to be discussed with the person and their emergency management plan should be updated to include what medications worked for them to control their seizures (in the emergency setting). The committee highlighted that people who have had status epilepticus seizures and their families or carers are given safety advice to follow, such as precautions around bathing, swimming and night-time supervision and would always be closely followed up in a seizure clinic over the next 6 – 12 months.</p></div></div></div></div><div id="niceng217er9.s1.5"><h3>1.5. Recommendations supported by this evidence review</h3><p>This evidence review supports recommendations 7.1.1 to 7.1.12 in the NICE guideline.</p></div></div><div id="niceng217er9.rl.r1"><h2 id="_niceng217er9_rl_r1_">References</h2><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="niceng217er9.ref1">Abdelgadir
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|
RE, McIntyre
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JW, Choonara
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IA, Whitehouse
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WP, Robertson
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S, Norris
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E. Randomised controlled trial of buccal midazolam versus rectal diazepam for the emergency treatment of seizures in children. Epilepsia. 2004; 45(Suppl 7):186 [<a href="https://pubmed.ncbi.nlm.nih.gov/16023510" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16023510</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>12.</dt><dd><div class="bk_ref" id="niceng217er9.ref12">Arya
|
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R, Kothari
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H, Zhang
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Z, Han
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B, Horn
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PS, Glauser
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TA. Efficacy of nonvenous medications for acute convulsive seizures: A network meta-analysis. Neurology. 2015; 85(21):1859–1868 [<a href="/pmc/articles/PMC4662705/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4662705</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26511448" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26511448</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>13.</dt><dd><div class="bk_ref" id="niceng217er9.ref13">Ashrafi
|
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MR, Khosroshahi
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N, Karimi
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P, Malamiri
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RA, Bavarian
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B, Zarch
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AV
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LKF, Obligar
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PDP, Panlilio
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JR, Pasco
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A, Martin
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A, Claassen
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J. Advancements in the critical care management of status epilepticus. Current Opinion in Critical Care. 2017; 23(2):122–127 [<a href="https://pubmed.ncbi.nlm.nih.gov/28207600" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28207600</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>16.</dt><dd><div class="bk_ref" id="niceng217er9.ref16">Bayrlee
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A, Ganeshalingam
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N, Kurczewski
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L, Brophy
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GM. Treatment of super-refractory status epilepticus. Current Neurology and Neuroscience Reports. 2015; 15(10):66 [<a href="https://pubmed.ncbi.nlm.nih.gov/26299274" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26299274</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>17.</dt><dd><div class="bk_ref" id="niceng217er9.ref17">Baysun, Aydin, O F, Atmaca, Gurer, Y K. A comparison of buccal midazolam and rectal diazepam for the acute treatment of seizures. Clinical Pediatrics. 2005; 44(9):771–776 [<a href="https://pubmed.ncbi.nlm.nih.gov/16327963" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16327963</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>18.</dt><dd><div class="bk_ref" id="niceng217er9.ref18">Bebin
|
|
EM, Lloyd
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JC, Santilli
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NF, Homzie-Schlesinger
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RR, Bright
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SE, Dreifuss
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FE. Results of open label follow on study for rectal diazepam in the treatment of acute repetitive seizures. Epilepsia. 1994; 35(Suppl 8):144</div></dd></dl><dl class="bkr_refwrap"><dt>19.</dt><dd><div class="bk_ref" id="niceng217er9.ref19">Beghi
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E, Capovilla
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G, Franzoni
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E, Minicucci
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F, Romeo
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A, Verrotti
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PS. Randomized controlled trials in status epilepticus. Epilepsia. 2008; 49(7):1288 [<a href="https://pubmed.ncbi.nlm.nih.gov/18638285" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18638285</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>21.</dt><dd><div class="bk_ref" id="niceng217er9.ref21">Bhattacharyya
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M, Kalra
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V, Gulati
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S. Intranasal midazolam vs rectal diazepam in acute childhood seizures. Pediatric Neurology. 2006; 34(5):355–359 [<a href="https://pubmed.ncbi.nlm.nih.gov/16647994" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16647994</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>22.</dt><dd><div class="bk_ref" id="niceng217er9.ref22">Bleck
|
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T, Cock
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H, Chamberlain
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J, Cloyd
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J, Connor
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J, Elm
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et al. The established status epilepticus trial 2013. Epilepsia. 2013; 54(Suppl 6):89–92 [<a href="/pmc/articles/PMC4048827/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4048827</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/24001084" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24001084</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>23.</dt><dd><div class="bk_ref" id="niceng217er9.ref23">BMJ Group and the Royal Pharmaceutical Society of Great Britain. British National Formulary. Available from: <a href="https://www.evidence.nhs.uk/formulary/bnf/current" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.evidence<wbr style="display:inline-block"></wbr>​.nhs.uk/formulary/bnf/current</a> Last accessed: 04 April 2017.</div></dd></dl><dl class="bkr_refwrap"><dt>24.</dt><dd><div class="bk_ref" id="niceng217er9.ref24">Brigo
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F, Bragazzi
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N, Nardone
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R, Trinka
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E. Direct and indirect comparison meta-analysis of levetiracetam versus phenytoin or valproate for convulsive status epilepticus. Epilepsy & Behavior. 2016; 64(Pt A):110–115 [<a href="https://pubmed.ncbi.nlm.nih.gov/27736657" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27736657</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>25.</dt><dd><div class="bk_ref" id="niceng217er9.ref25">Brigo
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F, Bragazzi
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NL, Bacigaluppi
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S, Nardone
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R, Trinka
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E. Is intravenous lorazepam really more effective and safe than intravenous diazepam as first-line treatment for convulsive status epilepticus? A systematic review with meta-analysis of randomized controlled trials. Epilepsy & Behavior. 2016; 64(Pt A):29–36 [<a href="https://pubmed.ncbi.nlm.nih.gov/27732915" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27732915</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>26.</dt><dd><div class="bk_ref" id="niceng217er9.ref26">Brigo
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F, Bragazzi
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NL, Igwe
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SC, Nardone
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R, Trinka
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E. Topiramate in the treatment of generalized convulsive status epilepticus in adults: A systematic review with individual patient data analysis. Drugs. 2017; 77(1):67–74 [<a href="/pmc/articles/PMC5216088/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5216088</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28004305" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28004305</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>27.</dt><dd><div class="bk_ref" id="niceng217er9.ref27">Brigo
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F, Bragazzi
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NL, Lattanzi
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S, Nardone
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R, Trinka
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E. A critical appraisal of randomized controlled trials on intravenous phenytoin in convulsive status epilepticus. European Journal of Neurology. 2018; 25(3):451–463 [<a href="https://pubmed.ncbi.nlm.nih.gov/29288520" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29288520</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>28.</dt><dd><div class="bk_ref" id="niceng217er9.ref28">Brigo
|
|
F, Igwe
|
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SC, Nardone
|
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R, Tezzon
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F, Bongiovanni
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LG, Trinka
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E. A common reference-based indirect comparison meta-analysis of intravenous valproate versus intravenous phenobarbitone for convulsive status epilepticus. Epileptic Disorders. 2013; 15(3):314–323 [<a href="https://pubmed.ncbi.nlm.nih.gov/23981687" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23981687</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>29.</dt><dd><div class="bk_ref" id="niceng217er9.ref29">Brigo
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F, Lattanzi
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S, Nardone
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R, Trinka
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E. Intravenous brivaracetam in the treatment of status epilepticus: A systematic review. CNS Drugs. 2019; 33(8):771–781 [<a href="https://pubmed.ncbi.nlm.nih.gov/31342405" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31342405</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>30.</dt><dd><div class="bk_ref" id="niceng217er9.ref30">Brigo
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F, Lattanzi
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S, Rohracher
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A, Russo
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E, Meletti
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S, Grillo
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F, Nardone
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R, Tezzon
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F, Trinka
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E. A common reference-based indirect comparison meta-analysis of buccal versus intranasal midazolam for early status epilepticus. CNS Drugs. 2015; 29(9):741–757 [<a href="https://pubmed.ncbi.nlm.nih.gov/26293745" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26293745</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>32.</dt><dd><div class="bk_ref" id="niceng217er9.ref32">Brigo
|
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F, Nardone
|
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R, Tezzon
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F, Trinka
|
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E. Nonintravenous midazolam versus intravenous or rectal diazepam for the treatment of early status epilepticus: A systematic review with meta-analysis. Epilepsy & Behavior. 2015; 49:325–336 [<a href="https://pubmed.ncbi.nlm.nih.gov/25817929" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25817929</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>33.</dt><dd><div class="bk_ref" id="niceng217er9.ref33">Brigo
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F, Storti
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M, Del Felice
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A, Fiaschi
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A, Bongiovanni
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LG. IV Valproate in generalized convulsive status epilepticus: a systematic review. European Journal of Neurology. 2012; 19(9):1180–1191 [<a href="https://pubmed.ncbi.nlm.nih.gov/22182304" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22182304</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>34.</dt><dd><div class="bk_ref" id="niceng217er9.ref34">Cereghino
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JJ, Cloyd
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RI, North American Diastat Study Group. Rectal diazepam gel for treatment of acute repetitive seizures in adults. Archives of Neurology. 2002; 59(12):1915–1920 [<a href="https://pubmed.ncbi.nlm.nih.gov/12470180" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12470180</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>35.</dt><dd><div class="bk_ref" id="niceng217er9.ref35">Cereghino
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JJ, Mitchell
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WG, Murphy
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RL, Rosenfeld
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S, Goyal
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MK, Modi
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A, Singh
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P. Levetiracetam versus phenytoin in management of status epilepticus. Journal of Clinical Neuroscience. 2015; 22(6):959–963 [<a href="https://pubmed.ncbi.nlm.nih.gov/25899652" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25899652</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>37.</dt><dd><div class="bk_ref" id="niceng217er9.ref37">Chakravarthi
|
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S, Modi
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M, Goyal
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MK, Bhalla
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A, Mehta
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JM, Altieri
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MA, Futterman
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C, Young
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JM, Kapur
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J, Shinnar
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S, Elm
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J, Holsti
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M, Babcock
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JM, Okada
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P, Holsti
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M, Mahajan
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JM, Brown
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JM, Okada
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P, Holsti
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M, Mahajan
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KM, Vance
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WB, Gao
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R, Su
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YY, Zhao
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A, Mehvari
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J, Salari
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M, Gholami
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MR. A comparative assessment the efficacy of intravenous infusion of sodium valproate and phenytion in the treatment of status epilepticus. International Journal of Preventive Medicine. 2013; 4(Suppl 2):S216–221 [<a href="/pmc/articles/PMC3678221/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3678221</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/23776727" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23776727</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>44.</dt><dd><div class="bk_ref" id="niceng217er9.ref44">Collins
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SR, Borland
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ML, Furyk
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J, Bonisch
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M, Neutze
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J, Donath
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|
|
SR, Furyk
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J, Bonisch
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M, Oakley
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E, Borland
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M, Neutze
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|
TMR, Costa
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G, Bacellar
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A, Orsini
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M, Nascimento
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G, J., van der Geest
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P, Doelman
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G, Bertram
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E, Edelbroek
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P. A comparison of midazolam nasal spray and diazepam rectal solution for the residential treatment of seizure exacerbations. Epilepsia. 2010; 51(3):478–482 [<a href="https://pubmed.ncbi.nlm.nih.gov/19817813" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19817813</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>50.</dt><dd><div class="bk_ref" id="niceng217er9.ref50">DeMott
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JM, Slocum
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GW, Gottlieb
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M, Peksa
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GD. Levetiracetam vs. phenytoin as 2nd-line treatment for status epilepticus: A systematic review and meta-analysis. Epilepsy & Behavior. 2020; 111:107286 [<a href="https://pubmed.ncbi.nlm.nih.gov/32707535" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32707535</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>51.</dt><dd><div class="bk_ref" id="niceng217er9.ref51">DeToledo
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JC, Ramsay
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D. Controlling seizures in children: Diazepam or midazolam? Systematic review. Hong Kong Journal of Emergency Medicine. 2010; 17(2):196–204</div></dd></dl><dl class="bkr_refwrap"><dt>53.</dt><dd><div class="bk_ref" id="niceng217er9.ref53">Dreifuss
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FE, Rosman
|
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NP, Cloyd
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JC, Pellock
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JM, Kuzniecky
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RI, Lo
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A, Karimzadeh
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P, Torabian
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S, Damadi
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S, Khajeh
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A. Comparison of intravenous midazolam drip with intermittent intravenous diazepam in the treatment of refractory serial seizures in children. Iranian Journal of Child Neurology. 2012; 6(3):15–19 [<a href="/pmc/articles/PMC3943030/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3943030</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/24665267" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24665267</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>55.</dt><dd><div class="bk_ref" id="niceng217er9.ref55">Fallah
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R, Gofrani
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M. Comparison of intravenous lidocaine and midazolam infusion for refractory convulsive status epilepticus in children. Journal of Pediatric Neurology. 2007; 5(4):287–290</div></dd></dl><dl class="bkr_refwrap"><dt>56.</dt><dd><div class="bk_ref" id="niceng217er9.ref56">Farrokh
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S, Bon
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J, Erdman
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M, Tesoro
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E. Use of newer anticonvulsants for the treatment of status epilepticus. Pharmacotherapy:The Journal of Human Pharmacology & Drug Therapy. 2019; 39(3):297–316 [<a href="https://pubmed.ncbi.nlm.nih.gov/30723940" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30723940</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>57.</dt><dd><div class="bk_ref" id="niceng217er9.ref57">Fisgin
|
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T, Gurer
|
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Y, Tezic
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T, Senbil
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N, Zorlu
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P, Okuyaz
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BJ, Okos
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AJ, Miller
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JW. Treatment of out-of-hospital status epilepticus with diazepam rectal gel. Seizure. 2003; 12(1):52–55 [<a href="https://pubmed.ncbi.nlm.nih.gov/12495650" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12495650</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>59.</dt><dd><div class="bk_ref" id="niceng217er9.ref59">Gathwala
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G, Goel
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M, Singh
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J, Mittal
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K. Intravenous diazepam, midazolam and lorazepam in acute seizure control. Indian Journal of Pediatrics. 2012; 79(3):327–332 [<a href="https://pubmed.ncbi.nlm.nih.gov/21713599" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21713599</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>60.</dt><dd><div class="bk_ref" id="niceng217er9.ref60">Gilad
|
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R, Izkovitz
|
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N, Dabby
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R, Rapoport
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A, Sadeh
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M, Weller
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T, Shinnar
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S, Gloss
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D, Alldredge
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B, Arya
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R, Bainbridge
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|
D, Pimentel
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J, Bentes
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C, Aguiar de Sousa
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D, Antunes
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AP, Alvarez
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|
|
AR, Nandhagopal
|
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R, Jacob
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PC, Al-Hashim
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A, Al-Amrani
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K, Ganguly
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SS
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PI, Rulian
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F, Saharso
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D. Comparison of intranasal midazolam and rectal diazepam as anticonvulsant in children. Journal of Nepal Paediatric Society. 2015; 35(2):117–122</div></dd></dl><dl class="bkr_refwrap"><dt>65.</dt><dd><div class="bk_ref" id="niceng217er9.ref65">Handral
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A, Veerappa
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BG, Gowda
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VK, Shivappa
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SK, Benakappa
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N, Benakappa
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A. Levetiracetam versus fosphenytoin in pediatric convulsive status epilepticus: A randomized controlled trial. Journal of Pediatric Neurosciences. 2020; 15(3):252–256 [<a href="/pmc/articles/PMC7847106/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7847106</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/33531940" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33531940</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>66.</dt><dd><div class="bk_ref" id="niceng217er9.ref66">Hofler
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J, Trinka
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E. Lacosamide as a new treatment option in status epilepticus. Epilepsia. 2013; 54(3):393–404 [<a href="https://pubmed.ncbi.nlm.nih.gov/23293881" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23293881</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>67.</dt><dd><div class="bk_ref" id="niceng217er9.ref67">Holsti
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M, Dudley
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N, Schunk
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J, Adelgais
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K, Greenberg
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R, Olsen
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M, Schunk
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J, Greenberg
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R, Dudley
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N, Adelgais
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K, Soprano
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J. Intranasal midazolam versus rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. Archives of Pediatrics and Adolescent Medicine. 2010; 164(8):747–753 [<a href="https://pubmed.ncbi.nlm.nih.gov/20679166" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20679166</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>69.</dt><dd><div class="bk_ref" id="niceng217er9.ref69">Huertas Gonzalez
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N, Barros Gonzalez
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A, Hernando Requejo
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V, Diaz Diaz
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J. Focal status epilepticus: a review of pharmacological treatment. Neurologia. 2019; 10.1016/j.nrl.2019.02.003 [<a href="https://pubmed.ncbi.nlm.nih.gov/31072691" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31072691</span></a>] [<a href="http://dx.crossref.org/10.1016/j.nrl.2019.02.003" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>70.</dt><dd><div class="bk_ref" id="niceng217er9.ref70">Husain
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AM. Lacosamide in status epilepticus: Update on the TRENdS study. Epilepsy & Behavior. 2015; 49:337–339 [<a href="https://pubmed.ncbi.nlm.nih.gov/26152818" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26152818</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>71.</dt><dd><div class="bk_ref" id="niceng217er9.ref71">Isguder
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R, Guzel
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O, Agin
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H, Yilmaz
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U, Akarcan
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SE, Celik
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P, Sharma
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S, Dua
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T, Barbui
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C, Das
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RR, Aneja
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M, Sheibani
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K, Hashemieh
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M, Saneifard
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H. Intranasal midazolam compared with intravenous diazepam in patients suffering from acute seizure: a randomized clinical trial. Iranian Journal of Pediatrics. 2012; 22(1):1–8 [<a href="/pmc/articles/PMC3448208/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3448208</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/23056852" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23056852</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>74.</dt><dd><div class="bk_ref" id="niceng217er9.ref74">Jenkinson
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E, Tulloch
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L, Tunnicliffe
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W. A randomised trial on the treatment of refractory status epilepticus. Journal of the Intensive Care Society. 2011; 12(3):246–247</div></dd></dl><dl class="bkr_refwrap"><dt>75.</dt><dd><div class="bk_ref" id="niceng217er9.ref75">Kapur
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J, Elm
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J, Chamberlain
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JM, Barsan
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W, Cloyd
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J, Lowenstein
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et al. Randomized Trial of Three Anticonvulsant Medications for Status Epilepticus. New England Journal of Medicine. 2019; 381(22):2103–2113 [<a href="/pmc/articles/PMC7098487/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7098487</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31774955" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31774955</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>76.</dt><dd><div class="bk_ref" id="niceng217er9.ref76">Kellinghaus
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C, Lang
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N, Rossetti
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AO, Ruegg
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S, Tilz
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C, Trinka
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|
|
C, Rossetti
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AO, Trinka
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E, Lang
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N, Unterberger
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I, Ruegg
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|
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A, Yaghoubinia
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F, Yaghoubi
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S, Fayyazi
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A, Miri Aliabad
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G. Comparison of the effect of phenobarbital versus sodium valproate in management of children with status epilepticus. Iranian Journal of Child Neurology. 2018; 12(4):85–93 [<a href="/pmc/articles/PMC6160621/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6160621</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30279711" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30279711</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>79.</dt><dd><div class="bk_ref" id="niceng217er9.ref79">Kinirons
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P, Doherty
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CP. Status epilepticus: a modern approach to management. European Journal of Emergency Medicine. 2008; 15(4):187–195 [<a href="https://pubmed.ncbi.nlm.nih.gov/19078813" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19078813</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>80.</dt><dd><div class="bk_ref" id="niceng217er9.ref80">Klowak
|
|
JA, Hewitt
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M, Catenacci
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|
V, Duffett
|
|
M, Rochwerg
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B, Jones
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K
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|
|
S, Gruener
|
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J, Hattemer
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|
K, Klein
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|
KM, Bauer
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S, Oertel
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WH
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|
|
H, Hifumi
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T, Hoshiyama
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E, Yamakawa
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K, Nakamura
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K, Soh
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M
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|
|
RL, Cloyd
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JC, Hadsall
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RS, Carlson
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AM, Floren
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KL, Jones-Saete
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CM. Home use of rectal diazepam for cluster and prolonged seizures: efficacy, adverse reactions, quality of life, and cost analysis. Pediatric Neurology. 1991; 7(1):13–17 [<a href="https://pubmed.ncbi.nlm.nih.gov/2029287" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2029287</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>85.</dt><dd><div class="bk_ref" id="niceng217er9.ref85">Kriel
|
|
RL, Cloyd
|
|
JC, Pellock
|
|
JM, Mitchell
|
|
WG, Cereghino
|
|
JJ, Rosman
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LC, Beechinor
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RJ, Chamberlain
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JM, Guptill
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JT, Harper
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B, Capparelli
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E, Goldman
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D, Hosking
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CS, Sutherland
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JM. Diazepam ("Valium") in the control of status epilepticus. Medical Journal of Australia. 1967; 1(11):542–545 [<a href="https://pubmed.ncbi.nlm.nih.gov/4960578" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 4960578</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>89.</dt><dd><div class="bk_ref" id="niceng217er9.ref89">Lambrechtsen
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JR. Aborted and refractory status epilepticus in children: a comparative analysis. Epilepsia. 2008; 49(4):615–625 [<a href="https://pubmed.ncbi.nlm.nih.gov/18093148" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18093148</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>90.</dt><dd><div class="bk_ref" id="niceng217er9.ref90">Langer
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JE, Fountain
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D, Gladwell
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D, Batty
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AJ, Brereton
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N, Tate
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|
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DC, Gladwell
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D, Hatswell
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AJ, Porter
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J, Brereton
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N, Tate
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HW, Seo
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HJ, Cohen
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LG, Bagic
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A, Theodore
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WH. Cortical excitability during prolonged antiepileptic drug treatment and drug withdrawal. Clinical Neurophysiology. 2005; 116(5):1105–1112 [<a href="https://pubmed.ncbi.nlm.nih.gov/15826851" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15826851</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>94.</dt><dd><div class="bk_ref" id="niceng217er9.ref94">Lee
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B, Depondt
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C, Levy-Nogueira
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M, Ligot
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N, Mavroudakis
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IE, Derivan
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AT, Homan
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L, Zhang
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Y, Jia
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L, Jia
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D, Faramand
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I, Siokas
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V, Brotis
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A, Zintzaras
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I, Dardiotis
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DH. Treatment options for status epilepticus. Current Opinion in Pharmacology. 2003; 3(1):6–11 [<a href="https://pubmed.ncbi.nlm.nih.gov/12550735" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12550735</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>103.</dt><dd><div class="bk_ref" id="niceng217er9.ref103">Lowenstein
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DH, Alldredge
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BK, Allen
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F, Neuhaus
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DH, Alldredge
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BK, Gelb
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AM, Isaacs
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SM, Corry
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DM, Allen
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MD, Gamble
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C, Messahel
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S, Hickey
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H, Iyer
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A, Woolfall
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|
|
MD, Rainford
|
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NEA, Gamble
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C, Messahel
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S, Humphreys
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A, Hickey
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SH, Rans
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C. Systematic review of clobazam use in patients with status epilepticus. Epilepsia Open. 2018; 3(3):323–330 [<a href="/pmc/articles/PMC6119756/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6119756</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30187002" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30187002</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>109.</dt><dd><div class="bk_ref" id="niceng217er9.ref109">Mahmoudian
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RA, Ghaempanah
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M, Khosroshahi
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N, Nikkhah
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A, Bavarian
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CK, Kahamba
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DM, Walker
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TD, Mukampunga
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C, Musalu
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EM, Kokolomani
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|
D, Gopala Krishna
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KN, Sanjib
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S, Chakrabarti
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D, Mundlamuri
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RC, Manohar
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SA, Claassen
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J, Lokin
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J, Mendelsohn
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BF. Refractory status epilepticus: frequency, risk factors, and impact on outcome. Archives of Neurology. 2002; 59(2):205–210 [<a href="https://pubmed.ncbi.nlm.nih.gov/11843690" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11843690</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>115.</dt><dd><div class="bk_ref" id="niceng217er9.ref115">McIntyre
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J, Robertson
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S, Norris
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E, Appleton
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R, Whitehouse
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WP, Phillips
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B. Outpatient pharmacotherapy and modes of administration for acute repetitive and prolonged seizures. CNS Drugs. 2015; 29(1):55–70 [<a href="https://pubmed.ncbi.nlm.nih.gov/25583219" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25583219</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>117.</dt><dd><div class="bk_ref" id="niceng217er9.ref117">McMullan
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J, Sasson
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C, Pancioli
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A, Kneen
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R, Kumar
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R, Spinty
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A, Martland
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|
UK, Dubey
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D, Kalita
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A, Wassmer
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AO, Milligan
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R, Lowenstein
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A, Zollner
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DH, Conwit
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R, Mahajan
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PV
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et al. Intramuscular midazolam versus intravenous lorazepam for the prehospital treatment of status epilepticus in the pediatric population. Epilepsia. 2015; 56(2):254–262 [<a href="/pmc/articles/PMC4386287/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4386287</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25597369" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25597369</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>240.</dt><dd><div class="bk_ref" id="niceng217er9.ref240">Wheless
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JW. Treatment of refractory convulsive status epilepticus in children: other therapies. Seminars in Pediatric Neurology. 2010; 17(3):190–194 [<a href="https://pubmed.ncbi.nlm.nih.gov/20727489" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20727489</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>241.</dt><dd><div class="bk_ref" id="niceng217er9.ref241">Wheless
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JW, Meng
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TC, Van Ess
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PJ, Detyniecki
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K, Sequeira
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DJ, Pullman
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WE. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters: An open-label extension trial. Epilepsia. 2019; 60(9):1809–1819 [<a href="https://pubmed.ncbi.nlm.nih.gov/31353457" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31353457</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>242.</dt><dd><div class="bk_ref" id="niceng217er9.ref242">Wheless
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JW, Treiman
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DM. The role of the newer antiepileptic drugs in the treatment of generalized convulsive status epilepticus. Epilepsia. 2008; 49(Suppl 9):74–78 [<a href="https://pubmed.ncbi.nlm.nih.gov/19087120" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19087120</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>243.</dt><dd><div class="bk_ref" id="niceng217er9.ref243">Wilkes
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R, Tasker
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RC. Intensive care treatment of uncontrolled status epilepticus in children: systematic literature search of midazolam and anesthetic therapies. Pediatric Critical Care Medicine. 2014; 15(7):632–639 [<a href="https://pubmed.ncbi.nlm.nih.gov/24901802" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24901802</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>244.</dt><dd><div class="bk_ref" id="niceng217er9.ref244">Wilkes
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R, Tasker
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RC. Pediatric intensive care treatment of uncontrolled status epilepticus. Critical Care Clinics. 2013; 29(2):239–257 [<a href="https://pubmed.ncbi.nlm.nih.gov/23537674" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23537674</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>245.</dt><dd><div class="bk_ref" id="niceng217er9.ref245">Willems
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LM, Bauer
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S, Rosenow
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F, Strzelczyk
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A. Recent advances in the pharmacotherapy of epilepsy: brivaracetam and perampanel as broad-spectrum antiseizure drugs for the treatment of epilepsies and status epilepticus. Expert Opinion on Pharmacotherapy. 2019; 20(14):1755–1765 [<a href="https://pubmed.ncbi.nlm.nih.gov/31264486" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31264486</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>246.</dt><dd><div class="bk_ref" id="niceng217er9.ref246">Won
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SY, Dubinski
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D, Sautter
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L, Hattingen
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E, Seifert
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V, Rosenow
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F
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et al. Seizure and status epilepticus in chronic subdural hematoma. Acta Neurologica Scandinavica. 2019; 140(3):194–203 [<a href="https://pubmed.ncbi.nlm.nih.gov/31102548" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31102548</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>247.</dt><dd><div class="bk_ref" id="niceng217er9.ref247">Wongjirattikarn
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R, Sawanyawisuth
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K, Pranboon
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S, Tiamkao
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S, Tiamkao
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S. Can generic intravenous levetiracetam be used for acute repetitive convulsive seizure or status epilepticus? A randomized controlled trial. Neurology & Therapy. 2019; 8(2):425–431 [<a href="/pmc/articles/PMC6858918/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6858918</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31407191" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31407191</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>248.</dt><dd><div class="bk_ref" id="niceng217er9.ref248">Xue
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T, Wei
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L, Shen
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X, Wang
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Z, Chen
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Z, Wang
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Z. Levetiracetam versus phenytoin for the pharmacotherapy of benzodiazepine-refractory status epilepticus: A systematic review and meta-analysis of randomized controlled trials. CNS Drugs. 2020; 34(12):1205–1215 [<a href="https://pubmed.ncbi.nlm.nih.gov/33111213" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33111213</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>249.</dt><dd><div class="bk_ref" id="niceng217er9.ref249">Yasiry
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Z, Shorvon
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SD. The relative effectiveness of five antiepileptic drugs in treatment of benzodiazepine-resistant convulsive status epilepticus: a meta-analysis of published studies. Seizure. 2014; 23(3):167–174 [<a href="https://pubmed.ncbi.nlm.nih.gov/24433665" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24433665</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>250.</dt><dd><div class="bk_ref" id="niceng217er9.ref250">Zelano
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J, Kumlien
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E. Levetiracetam as alternative stage two antiepileptic drug in status epilepticus: a systematic review. Seizure. 2012; 21(4):233–236 [<a href="https://pubmed.ncbi.nlm.nih.gov/22321334" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22321334</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>251.</dt><dd><div class="bk_ref" id="niceng217er9.ref251">Zhang
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Q, Yu
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Y, Lu
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Y, Yue
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H. Systematic review and meta-analysis of propofol versus barbiturates for controlling refractory status epilepticus. BMC Neurology. 2019; 19(1):55 [<a href="/pmc/articles/PMC6451279/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6451279</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30954065" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30954065</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>252.</dt><dd><div class="bk_ref" id="niceng217er9.ref252">Zhao
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ZY, Wang
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HY, Wen
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B, Yang
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ZB, Feng
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K, Fan
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JC. A comparison of midazolam, lorazepam, and diazepam for the treatment of status epilepticus in children: A network meta-analysis. Journal of Child Neurology. 2016; 31(9):1093–1107 [<a href="https://pubmed.ncbi.nlm.nih.gov/27021145" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27021145</span></a>]</div></dd></dl></dl></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng217er9.appa"><h3>Appendix A. Review protocols</h3><div id="niceng217er9.appa.s1"><h4>A.1. Review protocol: monotherapy for status epilepticus</h4><p id="niceng217er9.appa.et1"><a href="/books/NBK581143/bin/niceng217er9-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (195K)</span></p></div><div id="niceng217er9.appa.s2"><h4>A.2. Review protocol: add-on therapy for status epilepticus</h4><p id="niceng217er9.appa.et2"><a href="/books/NBK581143/bin/niceng217er9-appa-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (208K)</span></p></div><div id="niceng217er9.appa.s3"><h4>A.3. Health economic review protocol</h4><p id="niceng217er9.appa.et3"><a href="/books/NBK581143/bin/niceng217er9-appa-et3.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (172K)</span></p></div></div><div id="niceng217er9.appb"><h3>Appendix B. Literature search strategies</h3><p>This literature search strategy was used for the following reviews:
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<ul><li class="half_rhythm"><div>What AEDs (monotherapy) are effective in the treatment of repeated seizures or clusters of seizures?</div></li><li class="half_rhythm"><div>What AEDs (add-on therapy) are effective in the treatment of repeated seizures or clusters of seizures?</div></li><li class="half_rhythm"><div>What antiepileptic drugs (monotherapy) are effective in the treatment of status epilepticus?</div></li><li class="half_rhythm"><div>What antiepileptic drugs (add-on therapy) are effective in the treatment of status epilepticus?</div></li><li class="half_rhythm"><div>What AEDs (monotherapy) are effective in the treatment of prolonged seizures?</div></li></ul></p><p>The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.<a class="bibr" href="#niceng217er9.ref135" rid="niceng217er9.ref135"><sup>135</sup></a></p><p>For more information, please see the <a href="/books/NBK581143/bin/niceng217er9_bm1.pdf">Methodology</a> review published as part of the accompanying documents for this guideline.</p><div id="niceng217er9.appb.s1"><h4>B.1. Clinical search literature search strategy</h4><p id="niceng217er9.appb.et1"><a href="/books/NBK581143/bin/niceng217er9-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (259K)</span></p></div><div id="niceng217er9.appb.s2"><h4>B.2. Health Economics literature search strategy</h4><p id="niceng217er9.appb.et2"><a href="/books/NBK581143/bin/niceng217er9-appb-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (165K)</span></p></div></div><div id="niceng217er9.appc"><h3>Appendix C. Clinical evidence selection</h3><div id="niceng217er9.appc.s1"><h4>C.1. Monotherapy</h4><p id="niceng217er9.appc.et1"><a href="/books/NBK581143/bin/niceng217er9-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (142K)</span></p></div><div id="niceng217er9.appc.s2"><h4>C.2. Add on Therapies</h4><p id="niceng217er9.appc.et2"><a href="/books/NBK581143/bin/niceng217er9-appc-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (134K)</span></p></div></div><div id="niceng217er9.appd"><h3>Appendix D. Clinical evidence tables</h3><div id="niceng217er9.appd.s1"><h4>D.1. Monotherapy</h4><p id="niceng217er9.appd.et1"><a href="/books/NBK581143/bin/niceng217er9-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (558K)</span></p></div><div id="niceng217er9.appd.s2"><h4>D.2. Add on therapies</h4><p id="niceng217er9.appd.et2"><a href="/books/NBK581143/bin/niceng217er9-appd-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (489K)</span></p></div></div><div id="niceng217er9.appe"><h3>Appendix E. Forest plots</h3><div id="niceng217er9.appe.s1"><h4>E.1. Monotherapy</h4><p id="niceng217er9.appe.et1"><a href="/books/NBK581143/bin/niceng217er9-appe-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (254K)</span></p></div><div id="niceng217er9.appe.s2"><h4>E.2. Add on Therapy</h4><p id="niceng217er9.appe.et2"><a href="/books/NBK581143/bin/niceng217er9-appe-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (531K)</span></p></div></div><div id="niceng217er9.appf"><h3>Appendix F. GRADE tables</h3><div id="niceng217er9.appf.s1"><h4>F.1. Monotherapy</h4><p id="niceng217er9.appf.et1"><a href="/books/NBK581143/bin/niceng217er9-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (302K)</span></p></div><div id="niceng217er9.appf.s2"><h4>F.2. Add on therapies</h4><p id="niceng217er9.appf.et2"><a href="/books/NBK581143/bin/niceng217er9-appf-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (352K)</span></p></div></div><div id="niceng217er9.appg"><h3>Appendix G. Health economic evidence selection</h3><div id="niceng217er9.appg.s1"><h4>G.1. Monotherapy</h4><p id="niceng217er9.appg.et1"><a href="/books/NBK581143/bin/niceng217er9-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (153K)</span></p></div><div id="niceng217er9.appg.s2"><h4>G.2. Add on Therapy</h4><p id="niceng217er9.appg.et2"><a href="/books/NBK581143/bin/niceng217er9-appg-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (134K)</span></p></div></div><div id="niceng217er9.apph"><h3>Appendix H. Health economic evidence tables</h3><div id="niceng217er9.apph.s1"><h4>H.1. Monotherapy</h4><p id="niceng217er9.apph.et1"><a href="/books/NBK581143/bin/niceng217er9-apph-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (233K)</span></p></div><div id="niceng217er9.apph.s2"><h4>H.2. Add on Therapies</h4><p>None.</p></div></div><div id="niceng217er9.appi"><h3>Appendix I. Excluded studies</h3><div id="niceng217er9.appi.s1"><h4>I.1. Excluded clinical studies Monotherapy</h4><p id="niceng217er9.appi.et1"><a href="/books/NBK581143/bin/niceng217er9-appi-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (183K)</span></p></div><div id="niceng217er9.appi.s2"><h4>I.2. Excluded clinical studies Add on therapies</h4><p id="niceng217er9.appi.et2"><a href="/books/NBK581143/bin/niceng217er9-appi-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (167K)</span></p></div><div id="niceng217er9.appi.s3"><h4>I.3. Excluded health economic studies Monotherapy</h4><p id="niceng217er9.appi.et3"><a href="/books/NBK581143/bin/niceng217er9-appi-et3.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (120K)</span></p></div><div id="niceng217er9.appi.s4"><h4>I.4. Excluded health economic studies Add on therapies</h4><p id="niceng217er9.appi.et4"><a href="/books/NBK581143/bin/niceng217er9-appi-et4.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (120K)</span></p></div></div></div></div><div class="fm-sec"><div><p>FINAL</p></div><div><p>Evidence reviews underpinning recommendations 7.1.1 – 7.1.12 the NICE guideline</p><p>Developed by the National Guideline Centre</p></div><div><p><b>Disclaimer</b>: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.</p><p>Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2022.</div><div class="small"><span class="label">Bookshelf ID: NBK581143</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/35700299" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">35700299</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng217er9tab1"><div id="niceng217er9.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">PICO characteristics of review question</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng217er9.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng217er9.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Inclusion: Children, young people and adults with status epilepticus (convulsive and non-convulsive)</p>
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<p>Strata:</p>
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<p>Convulsive status epilepticus</p>
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<p>Non-convulsive status epilepticus (focal, myoclonic, absence)</p>
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<p>Exclusion: New-born babies (under 28 days) with acute symptomatic seizures</p>
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</td></tr><tr><th id="hd_b_niceng217er9.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Interventions</th><td headers="hd_b_niceng217er9.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Brivaracetam</p>
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<p>Carbamazepine (for focal motor status)</p>
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<p>Chlormethiazole (clomethiazole)</p>
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<p>Clobazam</p>
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<p>Clonazepam (for myoclonic status)</p>
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<p>Chloral hydrate</p>
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<p>Diazepam</p>
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<p>Eslicarbazepine</p>
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<p>Fosphenytoin</p>
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<p>Gabapentin</p>
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<p>General anaesthetic induction agents</p>
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<p>Immunotherapy</p>
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<p>Intravenous immunoglobulin</p>
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<p>Lacosamide</p>
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<p>Levetiracetam</p>
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<p>Lorazepam</p>
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<p>Midazolam</p>
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<p>Oxcarbazepine</p>
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<p>Paraldehyde</p>
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<p>Perampanel</p>
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<p>Phenobarbital (phenobarbitone)</p>
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<p>Phenytoin</p>
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<p>Pregabalin</p>
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<p>Rufinamide</p>
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<p>Steroids (methylprednisolone, prednisolone)</p>
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<p>Stiripentol</p>
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<p>Topiramate</p>
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<p>Valproate (sodium valproate/valproic acid)</p>
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<p>Zonisamide</p>
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<p>Dose according to prescriber discretion and/or local protocols</p>
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</td></tr><tr><th id="hd_b_niceng217er9.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparisons</th><td headers="hd_b_niceng217er9.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>One drug vs placebo/no treatment</div></li><li class="half_rhythm"><div>One drug vs another drug</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng217er9.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_niceng217er9.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>mortality (including SUDEP)</div></li><li class="half_rhythm"><div>time to seizure cessation, (5 min after drug administration, 10 min, 30 min, 60 min, 1 to 24 hours, up 24 hours for convulsive, non-convulsive- up to 1 month</div></li><li class="half_rhythm"><div>time to event seizure cessation</div></li><li class="half_rhythm"><div>seizure recurrence < within less than 24 hours after administration of monotherapy</div></li><li class="half_rhythm"><div>time to seizure recurrence after administration of monotherapy</div></li><li class="half_rhythm"><div>quality of life (QOLIE-31, QOLIE-AD-48)</div></li><li class="half_rhythm"><div>length of ICU stay</div></li><li class="half_rhythm"><div>length of hospital stay</div></li><li class="half_rhythm"><div>mean Glasgow outcome scale (% difference in the means between the two groups)</div></li><li class="half_rhythm"><div>adverse events
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<ul class="circle"><li class="half_rhythm"><div>respiratory depression</div></li><li class="half_rhythm"><div>hypotension</div></li><li class="half_rhythm"><div>frequency of endotracheal intubation</div></li><li class="half_rhythm"><div>ICU admission</div></li><li class="half_rhythm"><div>neuropsychological events such as confusion, anxiety, challenging behaviour, mood disturbance</div></li></ul></div></li><li class="half_rhythm"><div>healthcare resource use</div></li></ul></td></tr><tr><th id="hd_b_niceng217er9.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_niceng217er9.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p><ul><li class="half_rhythm"><div>RCTs</div></li><li class="half_rhythm"><div>Systematic reviews of RCTs</div></li></ul>
|
|
Exclusion: Non-English publications, non-randomised studies, conference abstracts</p>
|
|
<p>It is anticipated that there will be sufficient RCT evidence that there is no need to search for non-randomised studies.</p>
|
|
</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab2"><div id="niceng217er9.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of studies included in the evidence review</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Intervention</th><th id="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Comparison</th><th id="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">
|
|
<p>Population</p>
|
|
<p>Age</p>
|
|
<p>Top 3 causes of SE</p>
|
|
</th><th id="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Ahmad 2006<a class="bibr" href="#niceng217er9.ref5" rid="niceng217er9.ref5"><sup>5</sup></a></p>
|
|
<p>Malawi</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intranasal Lorazepam: 100 micrograms/kg</p>
|
|
<p>n=80</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intramuscular Paraldehyde: 0.2ml/kg</p>
|
|
<p>n=80</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>[median (IQR)]</p>
|
|
<p>Lorazepam – 18.5 months (9 to 33)</p>
|
|
<p>Paraldehyde – 19 months (10.5 to 36)</p>
|
|
<p>Lorazepam</p>
|
|
<p>Cerebral malaria: 49%</p>
|
|
<p>Protracted febrile convulsion: 20%</p>
|
|
<p>Metabolic derangement: 15%</p>
|
|
<p>Paraldehyde</p>
|
|
<p>Cerebral malaria: 55%</p>
|
|
<p>Protracted febrile convulsion: 19%</p>
|
|
<p>Metabolic derangement: 15%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at hospital discharge (no further details given)</p>
|
|
<p>Seizure recurrence within 24 hours</p>
|
|
<p>Termination of SE within 10 min</p>
|
|
<p>Time to seizure cessation</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Alldredge 2001<a class="bibr" href="#niceng217er9.ref7" rid="niceng217er9.ref7"><sup>7</sup></a></p>
|
|
<p>USA</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous diazepam: 5 mg</p>
|
|
<p>n=68</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Placebo</p>
|
|
<p>n=71</p>
|
|
<p>Intravenous lorazepam: 2 mg</p>
|
|
<p>n=66</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults</p>
|
|
<p>Diazepam</p>
|
|
<p>Low blood level of AEDs: 25.0%</p>
|
|
<p>Refractory epilepsy:11.8%</p>
|
|
<p>Alcohol abuse: 11.8%</p>
|
|
<p>Placebo</p>
|
|
<p>Low blood level of AEDs: 23.9%</p>
|
|
<p>Refractory epilepsy:8.5%</p>
|
|
<p>Alcohol abuse: 9.9%</p>
|
|
<p>Lorazepam</p>
|
|
<p>Low blood level of AEDs: 16.7%</p>
|
|
<p>Refractory epilepsy:13.6%</p>
|
|
<p>Alcohol abuse: 9.1%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at hospital discharge (no further details given)</p>
|
|
<p>Cessation of SE before arrival to ED</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Treatment out-of-hospital before arrival at ED</p>
|
|
<p>Mean time (SD) interval from study treatment to arrival at ED:</p>
|
|
<p>Diazepam: 15.9 (9.3) min</p>
|
|
<p>Placebo: 16.5 (8.2) min</p>
|
|
<p>Lorazepam: 16.2 (9.2) min</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Appleton 1995</p>
|
|
<p>UK<a class="bibr" href="#niceng217er9.ref10" rid="niceng217er9.ref10"><sup>10</sup></a></p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous/rectal lorazepam: 0.05 to 1.0 mg/kg, intravenously over 15 to 30 sec, children convulsing after 7 to 8 min after initial dose received a second dose</p>
|
|
<p>n=53</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous/rectal diazepam 0.3 to 0.4 mg/kg over 15 to 30 sec, children convulsing after 7 to 8 min after initial dose received a second dose</p>
|
|
<p>n=33</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (mean)</p>
|
|
<p>Lorazepam (IV = 6.6 years, rectal = 3.3 years)</p>
|
|
<p>Known epilepsy: 64%</p>
|
|
<p>Neurological disorder: 24%</p>
|
|
<p>Diazepam (IV = 5.2 years, rectal = 3.8 years)</p>
|
|
<p>Known epilepsy: 64%</p>
|
|
<p>Neurological disorder 22%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Cessation of seizures after 7-8 min</p>
|
|
<p>Seizure recurrence within 24 h</p>
|
|
<p>Hypotension</p>
|
|
<p>Time to seizure cessation</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Ashrafi 2010<a class="bibr" href="#niceng217er9.ref13" rid="niceng217er9.ref13"><sup>13</sup></a></p>
|
|
<p>Iran</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Buccal midazolam: 0.3 to 0.5 mg/kg</p>
|
|
<p>n=49</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Rectal diazepam: 0.5 mg/kg</p>
|
|
<p>n=49</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (median)</p>
|
|
<p>Buccal midazolam (24 months)</p>
|
|
<p>Generalised tonic-clonic seizures: 86%</p>
|
|
<p>Myoclonic seizures: 14%</p>
|
|
<p>Diazepam (48 months)</p>
|
|
<p>Generalised tonic-clonic seizures: 86%</p>
|
|
<p>Myoclonic seizures: 10%</p>
|
|
<p>Focal tonic seizure: 2%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 5 min</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Chamberlain 1997<a class="bibr" href="#niceng217er9.ref38" rid="niceng217er9.ref38"><sup>38</sup></a></p>
|
|
<p>USA</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous Midazolam: 0.2mg/kg (maximum 7 mg)</p>
|
|
<p>n=13</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous Diazepam: 0.3mg/kg (maximum 10 mg)</p>
|
|
<p>n=11</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (range 3 to 112 months)</p>
|
|
<p>Midazolam</p>
|
|
<p>Generalised tonic clonic: 77%</p>
|
|
<p>Partial motor seizures: 23%</p>
|
|
<p>Diazepam</p>
|
|
<p>Generalised tonic clonic: 45%</p>
|
|
<p>Partial motor seizures: 55%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Time to cessation after drug administration</p>
|
|
<p>Seizure recurrence within 24 hours</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Chamberlain 2014<a class="bibr" href="#niceng217er9.ref41" rid="niceng217er9.ref41"><sup>41</sup></a></p>
|
|
<p>USA</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous Diazepam: dose of 0.2 mg/kg of diazepam (maximum dose, 8 mg)</p>
|
|
<p>n=162</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous Lorazepam: 0.1 mg/kg of lorazepam (maximum dose, 4 mg)</p>
|
|
<p>n=148</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (range 3 months to 17.8 years)</p>
|
|
<p>Diazepam</p>
|
|
<p>Febrile: 35%</p>
|
|
<p>Low levels of anti-epileptic drugs: 8.6%</p>
|
|
<p>Acute symptomatic: 16.4%</p>
|
|
<p>Lorazepam</p>
|
|
<p>Febrile: 30.1%</p>
|
|
<p>Low levels of anti-epileptic drugs: 9.8%</p>
|
|
<p>Acute symptomatic: 11.3%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Termination of seizure within 10 min</p>
|
|
<p>Seizure recurrence within 24 hours</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Fisgin 2002<a class="bibr" href="#niceng217er9.ref57" rid="niceng217er9.ref57"><sup>57</sup></a></p>
|
|
<p>Turkey</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Rectal diazepam: 0.3 mg/kg</p>
|
|
<p>n=22</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intranasal midazolam: 0.2 mg/kg in 30 sec</p>
|
|
<p>n=23</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (mean)</p>
|
|
<p>Diazepam (2.02 years)</p>
|
|
<p>Generalised tonic clonic 64%</p>
|
|
<p>Simple febrile: 14%</p>
|
|
<p>Focal secondary generalised: 14%</p>
|
|
<p>Midazolam (3.8 years)</p>
|
|
<p>Generalised tonic clonic 62%</p>
|
|
<p>Simple febrile: 30%</p>
|
|
<p>Focal secondary generalised: 4%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure cessation at 10 min</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Gathwala 2012<a class="bibr" href="#niceng217er9.ref59" rid="niceng217er9.ref59"><sup>59</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous lorazepam: 0.1 mg/kg diluted in 3 to 5 cc normal saline, dose infused over 1 to 2 min at 1 to 2 mg/min, maximum dose was 4 mg per dose and if seizure persisted, one more dose was given after an interval of 5 to 10 min</p>
|
|
<p>n=40</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous diazepam: 0.3 mg/kg diluted in 3 to 5 cc normal, dose infused over 2 min at 2mg/min, maximum dose was 5 mg in children > 5 years old and 10 mg in children 5 years or older if seizure persisted a repeat dose was given after an interval of 5 to 10 min</p>
|
|
<p>n=40</p>
|
|
<p>Intravenous midazolam: 0.1 mg/kg diluted in 3 to 5 cc normal saline, dose infused over 1 to 2 min at 1 to 2 mg/min, maximum dose was 5 mg per dose and if seizure persisted, one more dose was given after an interval of 5 to 10 min</p>
|
|
<p>n=40</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (mean [SD])</p>
|
|
<p>Lorazepam (5.28 [2.97])</p>
|
|
<p>Seizure disorder: 83%</p>
|
|
<p>Meningitis/encephalitis: 15%</p>
|
|
<p>Neurocysticercosis: 2%</p>
|
|
<p>Diazepam (6.19 [3.63])</p>
|
|
<p>Seizure disorder: 88%</p>
|
|
<p>Meningitis/encephalitis: 10%</p>
|
|
<p>Neurocysticercosis: 2%</p>
|
|
<p>Midazolam (4.82 [2.48])</p>
|
|
<p>Seizure disorder: 85%</p>
|
|
<p>Meningitis/encephalitis: 13%</p>
|
|
<p>Neurocysticercosis: 2%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mean duration of seizure</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Lahat 2000<a class="bibr" href="#niceng217er9.ref87" rid="niceng217er9.ref87"><sup>87</sup></a></p>
|
|
<p>Israel</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intranasal Midazolam: 0.2 mg/kg. Midazolam solution (5 mg/ml) was dripped by syringe into both nostrils in equal doses, and an intravenous line was immediately introduced</p>
|
|
<p>n=21</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous Diazepam: dose of 0.3 mg/kg, the maximum dose being 10 mg.</p>
|
|
<p>n=23</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (range 6 to 40 months)</p>
|
|
<p>Midazolam</p>
|
|
<p>Upper respiratory tract infection: 43%</p>
|
|
<p>Acute otitis media: 26%</p>
|
|
<p>Bronchopneumonia: 14%</p>
|
|
<p>Diazepam</p>
|
|
<p>Upper respiratory tract infection: 47%</p>
|
|
<p>Acute otitis media: 17%</p>
|
|
<p>Bronchopneumonia: 17%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Time to cessation of seizure after drug administration</p>
|
|
<p>Treatment failure</p>
|
|
<p>Seizure recurrence</p>
|
|
<p>Adverse events</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Paediatric ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mahmoudian 2004<a class="bibr" href="#niceng217er9.ref110" rid="niceng217er9.ref110"><sup>110</sup></a></p>
|
|
<p>Iran</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intranasal Midazolam: solution (5mg/ml) was dropped by syringe into both nostrils in equal doses to those with even numbers and an intravenous line was immediately introduced.</p>
|
|
<p>n=35</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous diazepam: 0.2mg/kg was administered to patients with odd numbers after an intravenous line was introduced</p>
|
|
<p>n=35</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>(range 2 months to 15 years)</p>
|
|
<p>Midazolam</p>
|
|
<p>Hypocalcaemia: 0%</p>
|
|
<p>Febrile convulsions: 40%</p>
|
|
<p>CNS infection: 11%</p>
|
|
<p>Diazepam</p>
|
|
<p>Hypocalcaemia: 5%</p>
|
|
<p>Febrile convulsions: 3%</p>
|
|
<p>CNS infection: 29%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Seizure control within 10 min</p>
|
|
<p>Mean interval between drug administration and seizure control</p>
|
|
<p>Adverse events</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hospital</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Malu 2014<a class="bibr" href="#niceng217er9.ref112" rid="niceng217er9.ref112"><sup>112</sup></a></p>
|
|
<p>Democratic Republic of the Congo, Rwanda</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Rectal diazepam: was administered at a dose of 0.5 mg/kg of body weight of a 1mg/mL reconstituted solution</p>
|
|
<p>n=202</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Sublingual Lorazepam: was administered at a dose of 0.1 mg/kg of body weight, a 1 mg tablet was administered to children between 6 and 36 months old and 2.5 mg for those older than 4 years</p>
|
|
<p>n=234</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>(Interquartile range 17.75 months to 60 months)</p>
|
|
<p>Diazepam</p>
|
|
<p>Cerebral malaria: 59%</p>
|
|
<p>Epilepsy: 14%</p>
|
|
<p>Meningitis: 8%</p>
|
|
<p>Lorazepam</p>
|
|
<p>Cerebral malaria: 66%</p>
|
|
<p>Epilepsy: 9%</p>
|
|
<p>Meningitis: 7%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at 24 hours</p>
|
|
<p>Seizure cessation within
|
|
<dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>-</dt><dd><p class="no_top_margin">5 min</p></dd></dl><dl class="bkr_refwrap"><dt>-</dt><dd><p class="no_top_margin">10 min</p></dd></dl><dl class="bkr_refwrap"><dt>-</dt><dd><p class="no_top_margin">20 min</p></dd></dl></dl>
|
|
Seizure recurrence within 24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hospital</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mcintyre 2005<a class="bibr" href="#niceng217er9.ref115" rid="niceng217er9.ref115"><sup>115</sup></a></p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Buccal midazolam: the dose was determined by the child’s age and was designed to give about 0.5 mg per kg (2.5 mg for children aged 6 to 12 months, 5 mg for 1 to 4 years, 7.5mg for 5-9 years, 10 mg for 10 years and older), the intravenous preparation of midazolam hydrochloride, filtered through a needle or straw, was administered into the buccal cavity between the gum and cheeks</p>
|
|
<p>n=92</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Rectal diazepam: the dose was determined by the child’s age and was designed to give about 0.5 mg per kg (2.5 mg for children aged 6 to 12 months, 5 mg for 1 to 4 years, 7.5mg for 5-9 years, 10 mg for 10 years and older</p>
|
|
<p>n=85</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>(Interquartile range 1 to 6 years)</p>
|
|
<p>No information given on seizure causes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Seizure cessation within 10 min</p>
|
|
<p>Seizure recurrence</p>
|
|
<p>Respiratory depression</p>
|
|
<p>Time (min) to stop seizing after treatment</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Misra 2006<a class="bibr" href="#niceng217er9.ref126" rid="niceng217er9.ref126"><sup>126</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Valproate: received sodium valproate 30 mg/kg in 100 ml saline infused over 15 min</p>
|
|
<p>n=35</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Phenytoin: received Phenytoin sodium 18mg/kg in 100 ml saline infused immediately at a rate of 50mg/min</p>
|
|
<p>n=33</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children and adults (range 1 to 85 years; 12 participants aged 15 or under, 56 participants aged over 15)</p>
|
|
<p>Valproate</p>
|
|
<p>CNS infection: 60%</p>
|
|
<p>Cerebrovascular accident: 9%</p>
|
|
<p>Metabolic: 29%</p>
|
|
<p>Phenytoin</p>
|
|
<p>CNS infection: 52%</p>
|
|
<p>Cerebrovascular accident: 18%</p>
|
|
<p>Metabolic: 18%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Termination of SE after drug administration</p>
|
|
<p>Seizure recurrence within 24 hours</p>
|
|
<p>Seizure freedom at 24 hours</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">N/A</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Misra 2012<a class="bibr" href="#niceng217er9.ref125" rid="niceng217er9.ref125"><sup>125</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Lorazepam: 0.1 mg/kg in 10 ml saline IV in 2–4 min</p>
|
|
<p>n=41</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Levetiracetam: 20 mg/kg infused in 15 min</p>
|
|
<p>n=38</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults (mean=Lorazepam: 38.9, Levetiracetam: 39.16)</p>
|
|
<p>Lorazepam</p>
|
|
<p>CNS infection:54%</p>
|
|
<p>Stroke: 15%</p>
|
|
<p>Drug withdrawal: 2%</p>
|
|
<p>Levetiracetam</p>
|
|
<p>CNS infection: 42%</p>
|
|
<p>Stroke: 26%</p>
|
|
<p>Neurocysticercosis: 3%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at hospital discharge (no further details given)</p>
|
|
<p>Termination of SE within 30 min</p>
|
|
<p>Seizure recurrence within 24 hours</p>
|
|
<p>Seizure freedom at 24 hours</p>
|
|
<p>Respiratory failure hypotension</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hospital</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Momen 2015<a class="bibr" href="#niceng217er9.ref128" rid="niceng217er9.ref128"><sup>128</sup></a></p>
|
|
<p>Iran</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intramuscular midazolam: used with a dose of 0.3 mg/kg, injected into the left quadriceps muscle if the child was younger than 2 and if the child was older than 2 the left deltoid muscle was considered for injection.</p>
|
|
<p>n=50</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Rectal Diazepam: a dose of 0.5mg/kg was given.</p>
|
|
<p>n=50</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (Mean, SD)</p>
|
|
<p>Midazolam – 2 years (1.1)</p>
|
|
<p>Febrile status: 46%</p>
|
|
<p>Remote symptomatic: 30%</p>
|
|
<p>Idiopathic: 24%</p>
|
|
<p>Diazepam – 2.5 years (1.4)</p>
|
|
<p>Febrile status: 52%</p>
|
|
<p>Remote symptomatic: 20%</p>
|
|
<p>Idiopathic: 28%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Drug treatment successful</p>
|
|
<p>Seizure recurrence within 60 min</p>
|
|
<p>Time from arrival to stopping seizures</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mpimbaza 2008<a class="bibr" href="#niceng217er9.ref130" rid="niceng217er9.ref130"><sup>130</sup></a></p>
|
|
<p>Uganda</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Rectal diazepam and placebo midazolam: packaged in 2ml plastic syringes, both drugs were administered at ~0.5mg/kg (2.5 mg for 3-11 months, 5mg for 1-4 years, 7.5 for 5-9 years and 10mg for 10-12 years</p>
|
|
<p>n=165</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Buccal midazolam and placebo diazepam: drugs were administered at ~0.5mg/kg (2.5 mg for 3-11 months, 5mg for 1-4 years, 7.5 for 5-9 years and 10mg for 10-12 years</p>
|
|
<p>n=165</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>(interquartile range: 10.5 months to 36 months)</p>
|
|
<p>Diazepam</p>
|
|
<p>Febrile convulsion: 69.7%</p>
|
|
<p>Generalised convulsion: 81.2%</p>
|
|
<p>Focal: 18.8%</p>
|
|
<p>Midazolam</p>
|
|
<p>Febrile convulsion: 73.3%</p>
|
|
<p>Generalised convulsion: 81.8%</p>
|
|
<p>Focal: 18.2%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at hospital discharge (no further details given)</p>
|
|
<p>Seizure cessation within 10 min</p>
|
|
<p>Time to cessation of seizure</p>
|
|
<p>Seizure recurrence within 1 hour of initial control</p>
|
|
<p>Seizure recurrence within 24 hours</p>
|
|
<p>Respiratory depression</p>
|
|
<p>Time to cessation of seizure</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Acute Care Unit (ACU), the paediatric emergency unit of Mulago Hospital and the national referral hospital in Kampala.</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Silbergleit 2012<a class="bibr" href="#niceng217er9.ref187" rid="niceng217er9.ref187"><sup>187</sup></a><sup>,</sup>
|
|
<a class="bibr" href="#niceng217er9.ref189" rid="niceng217er9.ref189"><sup>189</sup></a><sup>,</sup>
|
|
<a class="bibr" href="#niceng217er9.ref239" rid="niceng217er9.ref239"><sup>239</sup></a></p>
|
|
<p>USA</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intramuscular midazolam and intravenous placebo: all adults and those children with an estimated body weight of more than 40 kg received 10 mg of intramuscular midazolam followed by intravenous placebo, in children with an estimated weight of 13 to 40 kg, the active treatment was 5 mg of intramuscular midazolam</p>
|
|
<p>n=448</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous lorazepam and intramuscular placebo: all adults and those children with an estimated body weight of more than 40 kg received intramuscular placebo followed by 4 mg of intravenous lorazepam, in children with an estimated weight of 13 to 40 kg, the active treatment was 2 mg of intravenous lorazepam</p>
|
|
<p>n=445</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children and Adults (Mean, SD)</p>
|
|
<p>Midazolam – 43 years (22) (range=0 to 102)</p>
|
|
<p>Noncompliance with or discontinuation of anticonvulsant therapy: 31%</p>
|
|
<p>Idiopathic or breakthrough status epilepticus: 27%</p>
|
|
<p>Coexisting condition that lowered seizure threshold: 7%</p>
|
|
<p>Lorazepam – 44 years (22) (range=1 to 94)</p>
|
|
<p>Noncompliance with or discontinuation of anticonvulsant therapy: 32%</p>
|
|
<p>Idiopathic or breakthrough status epilepticus: 27%</p>
|
|
<p>Coexisting condition that lowered seizure threshold: 7%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Termination of SE at time of arrival at ED</p>
|
|
<p>Seizure recurrence within 24 hours</p>
|
|
<p>Length of hospital stay</p>
|
|
<p>Length of ICU stay</p>
|
|
<p>Hypotension</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Thakker 2013<a class="bibr" href="#niceng217er9.ref215" rid="niceng217er9.ref215"><sup>215</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intranasal midazolam: (0.2 mg/kg), midazolam solution (5 mg/ml) was dripped by syringe into both nostrils in equal doses, and an intravenous line was immediately introduced</p>
|
|
<p>n=27</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous diazepam: (0.3 mg/kg)</p>
|
|
<p>n=23</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (mean, SD)</p>
|
|
<p>Midazolam – 3.84 years (2.93)</p>
|
|
<p>Febrile convulsion: 11%</p>
|
|
<p>Seizure disorder: 26%</p>
|
|
<p>CNS infection: 26%</p>
|
|
<p>Diazepam</p>
|
|
<p>Febrile convulsion: 9%</p>
|
|
<p>Seizure disorder: 26%</p>
|
|
<p>CNS infection: 26%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Time to cessation after drug administration</p>
|
|
<p>Treatment successful</p>
|
|
<p>Seizure recurrence within 24hours</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Paediatric ED</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Tonekaboni 2012<a class="bibr" href="#niceng217er9.ref217" rid="niceng217er9.ref217"><sup>217</sup></a></p>
|
|
<p>Iran</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Buccal midazolam: 2.5 mg for children aged 6-12 months, 5 mg for 1-4 years, 7.5 mg for 5-9 years, and 10 mg for 10 years or older</p>
|
|
<p>n=32</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous diazepam: 0.3 mg/kg/dose and through an intravenous line</p>
|
|
<p>n=60</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children (mean, SD = 17.5 months (10.1))</p>
|
|
<p>Midazolam</p>
|
|
<p>Tonic seizures: 28%</p>
|
|
<p>Tonic-clonic seizures: 56%</p>
|
|
<p>Atonic seizures: 16%</p>
|
|
<p>Diazepam</p>
|
|
<p>Tonic seizures: 18%</p>
|
|
<p>Tonic-clonic seizures: 67%</p>
|
|
<p>Atonic seizures: 15%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Termination of seizure within 10 min</p>
|
|
<p>Time to cessation after drug administration</p>
|
|
<p>Hypotension</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The paediatric emergency ward of Mofid Children’s Hospital</td></tr><tr><td headers="hd_h_niceng217er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Treiman 1998<a class="bibr" href="#niceng217er9.ref221" rid="niceng217er9.ref221"><sup>221</sup></a></p>
|
|
<p>USA</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Lorazepam: administered by means of Tubex injection at a maximal rate of 0.5 ml per min.</p>
|
|
<p>n=136</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Phenobarbital: administered at a rate of 1 ml per min to produce the maximal rates of drug infusion</p>
|
|
<p>n=124</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Phenytoin: administered at a rate of 1 ml per minute to produce the maximal rates of drug infusion.</p>
|
|
<p>n=127</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults (mean= overt: 58.6 years, subtle: 62 years)</p>
|
|
<p>Overt SE</p>
|
|
<p>Remote neurologic cause: 69.5%</p>
|
|
<p>Acute neurologic cause: 27.3%</p>
|
|
<p>Life-threatening medical condition: 32%</p>
|
|
<p>Cardiopulmonary arrest: 6.3%</p>
|
|
<p>Toxic effects of therapeutic or recreational Drug: 6.3%</p>
|
|
<p>Alcohol withdrawal: 6.5%</p>
|
|
<p>Subtle SE</p>
|
|
<p>Remote neurologic cause: 34.3%</p>
|
|
<p>Acute neurologic cause: 37.3%</p>
|
|
<p>Life-threatening medical condition: 56.7%</p>
|
|
<p>Cardiopulmonary arrest: 38.1%</p>
|
|
<p>Toxic effects of therapeutic or recreational Drug: 5.2%</p>
|
|
<p>Alcohol withdrawal: 0.7%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension</td><td headers="hd_h_niceng217er9.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Veterans Affairs medical centres and 6 affiliated university hospitals</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab3"><div id="niceng217er9.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Clinical evidence summary: Diazepam versus placebo</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab3_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab3_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab3_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab3_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab3_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab3_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab3_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab3_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab3_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab3_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab3_1_1_1_5" id="hd_h_niceng217er9.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Placebo</th><th headers="hd_h_niceng217er9.tab3_1_1_1_5" id="hd_h_niceng217er9.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Diazepam (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE at time of arrival at ED: adults</td><td headers="hd_h_niceng217er9.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>139</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 2.02</p>
|
|
<p>(1.19 to 3.42)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab3_1_1_1_5 hd_h_niceng217er9.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">211 per 1000</td><td headers="hd_h_niceng217er9.tab3_1_1_1_5 hd_h_niceng217er9.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>215 more per 1000</p>
|
|
<p>(from 40 more to 511 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab3_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab4"><div id="niceng217er9.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">Clinical evidence summary: Diazepam versus drugs (lorazepam, or midazolam)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab4_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab4_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab4_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab4_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab4_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab4_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab4_1_1_1_5" id="hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Drug</th><th headers="hd_h_niceng217er9.tab4_1_1_1_5" id="hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Diazepam (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality - vs lorazepam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>436</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.99</p>
|
|
<p>(0.8 to 4.95)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">30 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>30 more per 1000</p>
|
|
<p>(from 6 fewer to 118 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality - vs midazolam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>330</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.5</p>
|
|
<p>(0.63 to 3.57)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">48 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>24 more per 1000</p>
|
|
<p>(from 18 fewer to 125 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE at time of arrival at ED - vs lorazepam: adults</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>134</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.72</p>
|
|
<p>(0.51 to 1.01)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">591 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>165 fewer per 1000</p>
|
|
<p>(from 290 fewer to 6 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE within 5 min - vs midazolam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>98</p>
|
|
<p>(1 study)</p>
|
|
<p>5 min</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.82</p>
|
|
<p>(0.71 to 0.94)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1000 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>180 fewer per 1000</p>
|
|
<p>(from 60 fewer to 290 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE within 5 min - vs lorazepam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>436</p>
|
|
<p>(1 study)</p>
|
|
<p>5 min</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.37</p>
|
|
<p>(1.05 to 1.8)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">278 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>103 more per 1000</p>
|
|
<p>(from 14 more to 222 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of seizure within 10 min - vs midazolam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>714</p>
|
|
<p>(6 studies)</p>
|
|
<p>10 min</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup><sup>,</sup><sup>3</sup></p>
|
|
<p>due to risk of bias, imprecision, inconsistency</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.87</p>
|
|
<p>(0.71 to 1.08)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">744 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>97 fewer per 1000</p>
|
|
<p>(from 216 fewer to 59 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of seizure within 10 min - vs lorazepam (rectal/sublingual): children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>436</p>
|
|
<p>(1 study)</p>
|
|
<p>10 min</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.41</p>
|
|
<p>(1.24 to 1.62)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">560 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>230 more per 1000</p>
|
|
<p>(from 134 more to 347 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of seizure within 10 min - vs lorazepam (IV administration): children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>273</p>
|
|
<p>(1 study)</p>
|
|
<p>10 min</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.99</p>
|
|
<p>(0.85 to 1.14)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">729 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>7 fewer per 1000</p>
|
|
<p>(from 109 fewer to 102 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of seizure within 20 min - vs lorazepam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>436</p>
|
|
<p>(1 study)</p>
|
|
<p>20 min</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.1</p>
|
|
<p>(1.02 to 1.18)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">829 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>83 more per 1000</p>
|
|
<p>(from 17 more to 149 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time to clinical seizure cessation - vs lorazepam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>80</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to clinical seizure cessation in the control groups was</p>
|
|
<p>91.2</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to clinical seizure cessation in the intervention groups was</p>
|
|
<p>6.26 lower</p>
|
|
<p>(20.27 lower to 7.75 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time to cessation after drug administration - vs midazolam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>360</p>
|
|
<p>(6 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to cessation after drug administration in the control groups was</p>
|
|
<p>1.25</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to cessation after drug administration in the intervention groups was</p>
|
|
<p>1.45 lower</p>
|
|
<p>(1.62 to 1.29 lower)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours - vs midazolam (UK): children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>535</p>
|
|
<p>(6 studies)</p>
|
|
<p>24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.34</p>
|
|
<p>(1.03 to 1.76)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">216 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>262 more per 1000</p>
|
|
<p>(from 73 more to 1.64 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours - vs lorazepam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>634</p>
|
|
<p>(2 studies)</p>
|
|
<p>24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.06</p>
|
|
<p>(0.87 to 1.29)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">372 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>22 more per 1000</p>
|
|
<p>(from 48 fewer to 108 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, respiratory depression - vs midazolam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>875</p>
|
|
<p>(8 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.67</p>
|
|
<p>(0.66 to 4.22)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">14 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>14 fewer per 1000</p>
|
|
<p>(from 5 fewer to 44 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, respiratory depression - vs midazolam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>390</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 1.49</p>
|
|
<p>(0.95 to 2.34)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">287 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>80 more per 1000</p>
|
|
<p>(from 10 fewer to 170 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, hypotension: - vs midazolam: children</td><td headers="hd_h_niceng217er9.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>92</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.69</p>
|
|
<p>(0.28 to 1.67)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">219 per 1000</td><td headers="hd_h_niceng217er9.tab4_1_1_1_5 hd_h_niceng217er9.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>68 fewer per 1000</p>
|
|
<p>(from 157 fewer to 147 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab4_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab4_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl><dl class="bkr_refwrap"><dt>3</dt><dd><div id="niceng217er9.tab4_3"><p class="no_margin">Downgraded by 1 or 2 increments because of heterogeneity I<sup>2</sup>=86%, p<0.00001, unexplained by subgroup analysis</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab5"><div id="niceng217er9.tab5" class="table"><h3><span class="label">Table 5</span><span class="title">Clinical evidence summary: Lorazepam versus placebo</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab5/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab5_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab5_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab5_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab5_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab5_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab5_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab5_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab5_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab5_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab5_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab5_1_1_1_5" id="hd_h_niceng217er9.tab5_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Placebo</th><th headers="hd_h_niceng217er9.tab5_1_1_1_5" id="hd_h_niceng217er9.tab5_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Lorazepam (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality: adults</td><td headers="hd_h_niceng217er9.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>137</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.49</p>
|
|
<p>(0.18 to 1.33)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab5_1_1_1_5 hd_h_niceng217er9.tab5_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">155 per 1000</td><td headers="hd_h_niceng217er9.tab5_1_1_1_5 hd_h_niceng217er9.tab5_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>79 fewer per 1000</p>
|
|
<p>(from 127 fewer to 51 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE at time of arrival at ED: adults</td><td headers="hd_h_niceng217er9.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>137</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 2.8</p>
|
|
<p>(1.71 to 4.58)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab5_1_1_1_5 hd_h_niceng217er9.tab5_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">211 per 1000</td><td headers="hd_h_niceng217er9.tab5_1_1_1_5 hd_h_niceng217er9.tab5_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>380 more per 1000</p>
|
|
<p>(from 150 more to 756 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab5_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab5_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab6"><div id="niceng217er9.tab6" class="table"><h3><span class="label">Table 6</span><span class="title">Clinical evidence summary: Lorazepam versus drugs (diazepam, levetiracetam, paraldehyde, phenobarbital or phenytoin)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab6/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab6_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab6_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab6_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab6_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab6_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab6_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab6_1_1_1_5" id="hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Drug</th><th headers="hd_h_niceng217er9.tab6_1_1_1_5" id="hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Lorazepam (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality - vs diazepam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>134</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.72</p>
|
|
<p>(0.43 to 6.9)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">44 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>32 more per 1000</p>
|
|
<p>(from 25 fewer to 260 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality - vs levetiracetam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>44</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.99</p>
|
|
<p>(0.5 to 1.94)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">435 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>4 fewer per 1000</p>
|
|
<p>(from 217 fewer to 409 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality - vs paraldehyde: children</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>160</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.15</p>
|
|
<p>(0.59 to 2.27)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">162 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>24 more per 1000</p>
|
|
<p>(from 67 fewer to 206 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE within 10 min- - vs diazepam: children</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>61</p>
|
|
<p>(1 study)</p>
|
|
<p>10 min</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.09</p>
|
|
<p>(0.77 to 1.54)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">647 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>58 more per 1000</p>
|
|
<p>(from 149 fewer to 349 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE within 10 min- - vs paraldehyde: children</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>160</p>
|
|
<p>(1 study)</p>
|
|
<p>10 min</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.22</p>
|
|
<p>(0.99 to 1.52)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">612 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>135 more per 1000</p>
|
|
<p>(from 6 fewer to 318 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE at time of arrival at ED - vs diazepam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>134</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.39</p>
|
|
<p>(0.99 to 1.95)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">426 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>166 more per 1000</p>
|
|
<p>(from 4 fewer to 405 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE at time of arrival at ED - vs midazolam: adults and children</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>893</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.86</p>
|
|
<p>(0.79 to 0.94)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">734 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>103 fewer per 1000</p>
|
|
<p>(from 44 fewer to 154 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE within 30 mins - vs levetiracetam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>79</p>
|
|
<p>(1 study)</p>
|
|
<p>30 min</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.99</p>
|
|
<p>(0.77 to 1.27)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">763 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>8 fewer per 1000</p>
|
|
<p>(from 176 fewer to 206 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time to seizure cessation- vs midazolam: children</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>80</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">HIGH</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation in the control groups was</p>
|
|
<p>92.69</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation in the intervention groups was</p>
|
|
<p>1.57 lower</p>
|
|
<p>(12.44 lower to 9.3 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours - vs diazepam: children</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>61</p>
|
|
<p>(1 study)</p>
|
|
<p>24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.63</p>
|
|
<p>(0.27 to 1.46)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">353 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>131 fewer per 1000</p>
|
|
<p>(from 258 fewer to 162 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours - vs levetiracetam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>79</p>
|
|
<p>(1 study)</p>
|
|
<p>24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.54</p>
|
|
<p>(0.62 to 3.84)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">158 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>85 more per 1000</p>
|
|
<p>(from 60 fewer to 448 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours - vs midazolam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>893</p>
|
|
<p>(1 study)</p>
|
|
<p>24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.93</p>
|
|
<p>(0.64 to 1.35)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">114 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>8 fewer per 1000</p>
|
|
<p>(from 41 fewer to 40 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours - vs paraldehyde: children</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>160</p>
|
|
<p>(1 study)</p>
|
|
<p>24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.73</p>
|
|
<p>(0.31 to 1.71)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">138 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>37 fewer per 1000</p>
|
|
<p>(from 95 fewer to 98 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure freedom at 24 hours - vs levetiracetam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>79</p>
|
|
<p>(1 study)</p>
|
|
<p>24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.85</p>
|
|
<p>(0.57 to 1.25)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">605 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>91 fewer per 1000</p>
|
|
<p>(from 260 fewer to 151 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Length of hospital stay (days) – vs midazolam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>536</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of hospital stay (days) in the control groups was</p>
|
|
<p>6.7</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of hospital stay (days) in the intervention groups was</p>
|
|
<p>1.2 lower</p>
|
|
<p>(2.64 lower to 0.24 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Length of ICU stay (days) - vs midazolam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>278</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of ICU stay (days) in the control groups was</p>
|
|
<p>5.7</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of ICU stay (days) in the intervention groups was</p>
|
|
<p>1.6 lower</p>
|
|
<p>(3.43 lower to 0.23 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, respiratory failure - vs levetiracetam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>44</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 2.19</p>
|
|
<p>(0.89 to 5.37)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">217 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>259 more per 1000</p>
|
|
<p>(from 24 fewer to 950 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, hypotension - vs diazepam: children</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>61</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.18</p>
|
|
<p>(0.02 to 1.37)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">206 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>169 fewer per 1000</p>
|
|
<p>(from 202 fewer to 76 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, hypotension - vs levetiracetam: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>44</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 4.38</p>
|
|
<p>(1.05 to 18.35)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">87 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>294 more per 1000</p>
|
|
<p>(from 4 more to 1000 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, hypotension - vs phenobarbital: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>260</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.77</p>
|
|
<p>(0.57 to 1.03)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">460 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>106 fewer per 1000</p>
|
|
<p>(from 198 fewer to 14 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, hypotension - vs phenytoin: adults</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>263</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.07</p>
|
|
<p>(0.76 to 1.49)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">331 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>23 more per 1000</p>
|
|
<p>(from 79 fewer to 162 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, hypotension - vs midazolam: adults and children</td><td headers="hd_h_niceng217er9.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>893</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.09</p>
|
|
<p>(0.5 to 2.36)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">27 per 1000</td><td headers="hd_h_niceng217er9.tab6_1_1_1_5 hd_h_niceng217er9.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>2 more per 1000</p>
|
|
<p>(from 13 fewer to 36 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab6_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab6_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab7"><div id="niceng217er9.tab7" class="table"><h3><span class="label">Table 7</span><span class="title">Clinical evidence summary: Valproate versus phenytoin</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab7/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab7_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab7_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab7_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab7_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab7_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab7_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab7_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab7_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab7_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab7_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab7_1_1_1_5" id="hd_h_niceng217er9.tab7_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Drug</th><th headers="hd_h_niceng217er9.tab7_1_1_1_5" id="hd_h_niceng217er9.tab7_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Valproate (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Termination of SE after drug infusion: children</td><td headers="hd_h_niceng217er9.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>68</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.55</p>
|
|
<p>(0.97 to 2.46)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_5 hd_h_niceng217er9.tab7_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">424 per 1000</td><td headers="hd_h_niceng217er9.tab7_1_1_1_5 hd_h_niceng217er9.tab7_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>233 more per 1000</p>
|
|
<p>(from 13 fewer to 619 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours: children</td><td headers="hd_h_niceng217er9.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>68</p>
|
|
<p>(1 study)</p>
|
|
<p>24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.44</p>
|
|
<p>(0.19 to 1.01)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_5 hd_h_niceng217er9.tab7_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">394 per 1000</td><td headers="hd_h_niceng217er9.tab7_1_1_1_5 hd_h_niceng217er9.tab7_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>221 fewer per 1000</p>
|
|
<p>(from 319 fewer to 4 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure freedom at 24 hours: children</td><td headers="hd_h_niceng217er9.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>68</p>
|
|
<p>(1 study)</p>
|
|
<p>24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.75</p>
|
|
<p>(0.34 to 1.68)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_5 hd_h_niceng217er9.tab7_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">303 per 1000</td><td headers="hd_h_niceng217er9.tab7_1_1_1_5 hd_h_niceng217er9.tab7_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>76 fewer per 1000</p>
|
|
<p>(from 200 fewer to 206 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, respiratory depression: children</td><td headers="hd_h_niceng217er9.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>37</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.3</p>
|
|
<p>(0.03 to 3.06)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab7_1_1_1_5 hd_h_niceng217er9.tab7_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">143 per 1000</td><td headers="hd_h_niceng217er9.tab7_1_1_1_5 hd_h_niceng217er9.tab7_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>100 fewer per 1000</p>
|
|
<p>(from 139 fewer to 294 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab7_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab7_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab8"><div id="niceng217er9.tab8" class="table"><h3><span class="label">Table 8</span><span class="title">Clinical evidence summary: Phenytoin versus phenobarbital</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab8/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab8_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab8_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab8_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab8_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab8_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab8_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab8_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab8_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab8_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab8_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab8_1_1_1_5" id="hd_h_niceng217er9.tab8_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Phenobarbital</th><th headers="hd_h_niceng217er9.tab8_1_1_1_5" id="hd_h_niceng217er9.tab8_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Phenytoin (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab8_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, hypotension</td><td headers="hd_h_niceng217er9.tab8_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>251</p>
|
|
<p>(1 study): adults</p>
|
|
</td><td headers="hd_h_niceng217er9.tab8_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab8_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.72</p>
|
|
<p>(0.53 to 0.98)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab8_1_1_1_5 hd_h_niceng217er9.tab8_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">460 per 1000</td><td headers="hd_h_niceng217er9.tab8_1_1_1_5 hd_h_niceng217er9.tab8_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>129 fewer per 1000</p>
|
|
<p>(from 9 fewer to 216 fewer)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab8_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab8_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab9"><div id="niceng217er9.tab9" class="table"><h3><span class="label">Table 9</span><span class="title">Health economic evidence profile: Buccolam versus standard care, buccal midazolam, and rectal diazepam</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab9/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab9_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab9_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng217er9.tab9_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Applicability</th><th id="hd_h_niceng217er9.tab9_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Limitations</th><th id="hd_h_niceng217er9.tab9_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Other comments</th><th id="hd_h_niceng217er9.tab9_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Incremental cost<sup>(c)</sup></th><th id="hd_h_niceng217er9.tab9_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Incremental effects</th><th id="hd_h_niceng217er9.tab9_1_1_1_7" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Cost effectiveness</th><th id="hd_h_niceng217er9.tab9_1_1_1_8" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Uncertainty</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab9_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Lee 2013<a class="bibr" href="#niceng217er9.ref91" rid="niceng217er9.ref91"><sup>91</sup></a> (Wales)</td><td headers="hd_h_niceng217er9.tab9_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Partially applicable<sup>(a)</sup></td><td headers="hd_h_niceng217er9.tab9_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Potentially serious limitations<sup>(b)</sup></td><td headers="hd_h_niceng217er9.tab9_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Probabilistic discrete event simulation and decision tree model based on single UK RCT (McIntyre 2005)<a class="bibr" href="#niceng217er9.ref115" rid="niceng217er9.ref115"><sup>115</sup></a></div></li><li class="half_rhythm"><div>Cost-utility analysis (QALYs)</div></li><li class="half_rhythm"><div>Population: Paediatric patients with a diagnosis of epilepsy suffering prolonged, acute, convulsive seizures in the community setting.</div></li><li class="half_rhythm"><div>Time horizon: 6 years, and also 1 year.</div></li><li class="half_rhythm"><div>Comparators:
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<dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1)</dt><dd><p class="no_top_margin">Standard care (95% buccal Midazolam, 5% rectal Diazepam)</p></dd></dl><dl class="bkr_refwrap"><dt>2)</dt><dd><p class="no_top_margin">Buccolam</p></dd></dl><dl class="bkr_refwrap"><dt>3)</dt><dd><p class="no_top_margin">Buccal Midazolam</p></dd></dl><dl class="bkr_refwrap"><dt>4)</dt><dd><p class="no_top_margin">Rectal Diazepam</p></dd></dl></dl></div></li></ul></td><td headers="hd_h_niceng217er9.tab9_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>(2−1): saves £2,939</p>
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|
<p>(2−3): saves£886</p>
|
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<p>(2−4): saves£14,269</p>
|
|
</td><td headers="hd_h_niceng217er9.tab9_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>(2−1): 0.025</p>
|
|
<p>(2−3): 0.013</p>
|
|
<p>(2−4): 0.082</p>
|
|
</td><td headers="hd_h_niceng217er9.tab9_1_1_1_7" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention 2 (Buccolam) dominates all other interventions.</td><td headers="hd_h_niceng217er9.tab9_1_1_1_8" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Probability Buccolam cost effective (£20/£30K threshold): NR</p>
|
|
<p>Probabilistic sensitivity analysis was performed with 10,000 Monte Carlo simulations.</p>
|
|
<p>Scenario analyses undertaken include Varying the shelf life of buccal Midazolam to make it shorter, having more doses per bottle of buccal Midazolam, having two bottles of unlicensed buccal Midazolam ordered per prescription (instead of 1) which lowers the cost), and Buccolam/unlicensed buccal Midazolam are as effective as diazepam rather than more effective. All showed Buccolam would still be cost saving.</p>
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</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Abbreviations: ICER= incremental cost-effectiveness ratio; QALY= quality-adjusted life years; RCT= randomised controlled trial</p></div></dd></dl><dl class="bkr_refwrap"><dt>(a)</dt><dd><div id="niceng217er9.tab9_1"><p class="no_margin">UK study (Wales), EQ-5D but filled in by clinicians not patients or their parents/carers.</p></div></dd></dl><dl class="bkr_refwrap"><dt>(b)</dt><dd><div id="niceng217er9.tab9_2"><p class="no_margin">Costs out of date: Buccal Midazolam in particular based on current BNF costs this would be more expensive now because only comes in one pre-filled syringe. But costs depend on dose and how it is packaged (separate pre-filled multiple syringes or not) so uncertainty about cost effectiveness based on which buccal product is used as there are generic versions available which are not listed in the BNF. Funded by manufacturers. Most inputs elicited from surveys and are assumptions.</p></div></dd></dl><dl class="bkr_refwrap"><dt>(c)</dt><dd><div id="niceng217er9.tab9_3"><p class="no_margin">Cost components incorporated: Drug costs, ambulance costs, hospital costs (inpatient admissions and ICU/HDU admissions).</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab10"><div id="niceng217er9.tab10" class="table"><h3><span class="label">Table 10</span><span class="title">Health economic evidence profile: Buccolam versus standard care, buccal midazolam, and rectal diazepam</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab10/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab10_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab10_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng217er9.tab10_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Applicability</th><th id="hd_h_niceng217er9.tab10_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Limitations</th><th id="hd_h_niceng217er9.tab10_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Other comments</th><th id="hd_h_niceng217er9.tab10_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Incremental cost</th><th id="hd_h_niceng217er9.tab10_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Incremental effects</th><th id="hd_h_niceng217er9.tab10_1_1_1_7" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Cost effectiveness</th><th id="hd_h_niceng217er9.tab10_1_1_1_8" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Uncertainty</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab10_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Lee 2014<a class="bibr" href="#niceng217er9.ref92" rid="niceng217er9.ref92"><sup>92</sup></a> (Scotland)</td><td headers="hd_h_niceng217er9.tab10_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Partially applicable<sup>(a)</sup></td><td headers="hd_h_niceng217er9.tab10_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Potentially serious limitations<sup>(b)</sup></td><td headers="hd_h_niceng217er9.tab10_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Discrete event simulation and decision tree model based on single UK RCT (McIntyre 2005)<a class="bibr" href="#niceng217er9.ref115" rid="niceng217er9.ref115"><sup>115</sup></a></div></li><li class="half_rhythm"><div>Cost-utility analysis (QALYs)</div></li><li class="half_rhythm"><div>Population: Paediatric patients with a diagnosis of epilepsy suffering prolonged, acute, convulsive seizures in the community setting.</div></li><li class="half_rhythm"><div>Time horizon: 1 year.</div></li><li class="half_rhythm"><div>Comparators:
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|
<dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1)</dt><dd><p class="no_top_margin">Standard care (100% buccal Midazolam)</p></dd></dl><dl class="bkr_refwrap"><dt>2)</dt><dd><p class="no_top_margin">Buccolam</p></dd></dl><dl class="bkr_refwrap"><dt>3)</dt><dd><p class="no_top_margin">Buccal Midazolam</p></dd></dl><dl class="bkr_refwrap"><dt>4)</dt><dd><p class="no_top_margin">Rectal Diazepam</p></dd></dl></dl></div></li></ul>
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|
<i>Note that 7 European perspectives were modelled, (Scotland, Wales, Germany, France, Spain, Italy, Switzerland)</i>. <i>The Welsh perspective is included in the previous paper. The most relevant remaining perspective to the UK is the Scottish perspective and therefore is the only perspective extracted here</i>.</td><td headers="hd_h_niceng217er9.tab10_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>(Scottish perspective)<sup>(c)</sup></p>
|
|
<p>(2−1): saves £322</p>
|
|
<p>(2−3): saves £322</p>
|
|
<p>(2−4): saves £1,494</p>
|
|
</td><td headers="hd_h_niceng217er9.tab10_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>(Scottish perspective)</p>
|
|
<p>(2−1): 0.00082</p>
|
|
<p>(2−3): 0.00082</p>
|
|
<p>(2−4): 0.00637</p>
|
|
</td><td headers="hd_h_niceng217er9.tab10_1_1_1_7" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention 2 (Buccolam) dominates all other interventions.</td><td headers="hd_h_niceng217er9.tab10_1_1_1_8" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Unclear if probabilistic analysis undertaken.</p>
|
|
<p>Upper and lower bounds of each parameter used in deterministic sensitivity analysis. The three most influential parameters on the results for the Scottish perspective were:
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|
<ul><li class="half_rhythm"><div>Probability carer doesn’t administer treatment with buccal midazolam.</div></li><li class="half_rhythm"><div>Probability carer doesn’t administer treatment with Buccolam.</div></li><li class="half_rhythm"><div>Probability of failed delivery of buccal midazolam.</div></li></ul></p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Abbreviations: ICER= incremental cost-effectiveness ratio; QALY= quality-adjusted life years; RCT= randomised controlled trial</p></div></dd></dl><dl class="bkr_refwrap"><dt>(a)</dt><dd><div id="niceng217er9.tab10_1"><p class="no_margin">Has a UK perspective, and uses EQ-5D but filled in by clinicians not patients or their parents/carers.</p></div></dd></dl><dl class="bkr_refwrap"><dt>(b)</dt><dd><div id="niceng217er9.tab10_2"><p class="no_margin">Costs out of date: Buccal Midazolam in particular based on current BNF costs this would be more expensive now because only comes in one pre-filled syringe. But costs depend on dose and how it is packaged (separate pre-filled multiple syringes or not) so uncertainty about cost effectiveness based on which buccal product is used as there are generic versions available which are not listed in the BNF. Funded by manufacturers. Most inputs elicited from surveys and are assumptions.</p></div></dd></dl><dl class="bkr_refwrap"><dt>(c)</dt><dd><div id="niceng217er9.tab10_3"><p class="no_margin">2012 Euros converted to 2012 UK pounds based on exchange rate reported in the paper (as costs were converted to Euros for country comparison in the paper).<a class="bibr" href="#niceng217er9.ref146" rid="niceng217er9.ref146"><sup>146</sup></a>. Cost components incorporated: Drug costs, ambulance costs, hospital costs (inpatient admissions and ICU/HDU admissions).</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab11"><div id="niceng217er9.tab11" class="table"><h3><span class="label">Table 11</span><span class="title">UK costs of drugs used for Status Epilepticus</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab11/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab11_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab11_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Drug</th><th id="hd_h_niceng217er9.tab11_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Description</th><th id="hd_h_niceng217er9.tab11_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost</th><th id="hd_h_niceng217er9.tab11_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Dose</th><th id="hd_h_niceng217er9.tab11_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost per dose</th><th id="hd_h_niceng217er9.tab11_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost source</th></tr></thead><tbody><tr><th headers="hd_h_niceng217er9.tab11_1_1_1_1 hd_h_niceng217er9.tab11_1_1_1_2 hd_h_niceng217er9.tab11_1_1_1_3 hd_h_niceng217er9.tab11_1_1_1_4 hd_h_niceng217er9.tab11_1_1_1_5" id="hd_b_niceng217er9.tab11_1_1_1_1" colspan="5" rowspan="1" style="text-align:left;vertical-align:top;">Lorazepam</th><th headers="hd_h_niceng217er9.tab11_1_1_1_6" id="hd_b_niceng217er9.tab11_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></th></tr><tr><td headers="hd_h_niceng217er9.tab11_1_1_1_1 hd_b_niceng217er9.tab11_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IV</td><td headers="hd_h_niceng217er9.tab11_1_1_1_2 hd_b_niceng217er9.tab11_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>4mg/ml</p>
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|
<p>10 ampoules</p>
|
|
</td><td headers="hd_h_niceng217er9.tab11_1_1_1_3 hd_b_niceng217er9.tab11_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£3.54</td><td headers="hd_h_niceng217er9.tab11_1_1_1_4 hd_b_niceng217er9.tab11_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">4mg</td><td headers="hd_h_niceng217er9.tab11_1_1_1_5 hd_b_niceng217er9.tab11_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.35</td><td headers="hd_h_niceng217er9.tab11_1_1_1_6 hd_b_niceng217er9.tab11_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">BNF (NHS indicative price)<sup>(a)</sup></td></tr><tr><th headers="hd_h_niceng217er9.tab11_1_1_1_1 hd_h_niceng217er9.tab11_1_1_1_2 hd_h_niceng217er9.tab11_1_1_1_3 hd_h_niceng217er9.tab11_1_1_1_4 hd_h_niceng217er9.tab11_1_1_1_5" id="hd_b_niceng217er9.tab11_1_1_3_1" colspan="5" rowspan="1" style="text-align:left;vertical-align:top;">Diazepam</th><th headers="hd_h_niceng217er9.tab11_1_1_1_6" id="hd_b_niceng217er9.tab11_1_1_3_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></th></tr><tr><td headers="hd_h_niceng217er9.tab11_1_1_1_1 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">IV</td><td headers="hd_h_niceng217er9.tab11_1_1_1_2 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>10mg/2ml</p>
|
|
<p>10 ampoules</p>
|
|
</td><td headers="hd_h_niceng217er9.tab11_1_1_1_3 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£5.50</td><td headers="hd_h_niceng217er9.tab11_1_1_1_4 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10mg</td><td headers="hd_h_niceng217er9.tab11_1_1_1_5 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.55</td><td headers="hd_h_niceng217er9.tab11_1_1_1_6 hd_b_niceng217er9.tab11_1_1_3_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">BNF (drug tariff price)</td></tr><tr><td headers="hd_h_niceng217er9.tab11_1_1_1_1 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Rectal</td><td headers="hd_h_niceng217er9.tab11_1_1_1_2 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>10mg/2.5ml</p>
|
|
<p>5 tubes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab11_1_1_1_3 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£5.90</td><td headers="hd_h_niceng217er9.tab11_1_1_1_4 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10mg</td><td headers="hd_h_niceng217er9.tab11_1_1_1_5 hd_b_niceng217er9.tab11_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£1.48</td><td headers="hd_h_niceng217er9.tab11_1_1_1_6 hd_b_niceng217er9.tab11_1_1_3_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">BNF (drug tariff price)</td></tr><tr><th headers="hd_h_niceng217er9.tab11_1_1_1_1 hd_h_niceng217er9.tab11_1_1_1_2 hd_h_niceng217er9.tab11_1_1_1_3 hd_h_niceng217er9.tab11_1_1_1_4 hd_h_niceng217er9.tab11_1_1_1_5 hd_h_niceng217er9.tab11_1_1_1_6" id="hd_b_niceng217er9.tab11_1_1_6_1" colspan="6" rowspan="1" style="text-align:left;vertical-align:top;">Midazolam</th></tr><tr><td headers="hd_h_niceng217er9.tab11_1_1_1_1 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Buccal (Oromucosal solution)<sup>(b)</sup></td><td headers="hd_h_niceng217er9.tab11_1_1_1_2 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Buccolam (Midazolam hydrochloride):</p>
|
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<p>10mg/2ml</p>
|
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<p>Pack of 4 pre-filled syringes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab11_1_1_1_3 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£91.50</td><td headers="hd_h_niceng217er9.tab11_1_1_1_4 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10mg</td><td headers="hd_h_niceng217er9.tab11_1_1_1_5 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£22.88</td><td headers="hd_h_niceng217er9.tab11_1_1_1_6 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">BNF (drug tariff price)</td></tr><tr><td headers="hd_h_niceng217er9.tab11_1_1_1_1 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab11_1_1_1_2 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Epistatus (Midazolam maleate):</p>
|
|
<p>10mg/ml</p>
|
|
<p>1 pre-filled syringe</p>
|
|
</td><td headers="hd_h_niceng217er9.tab11_1_1_1_3 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£45.76</td><td headers="hd_h_niceng217er9.tab11_1_1_1_4 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10mg</td><td headers="hd_h_niceng217er9.tab11_1_1_1_5 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£45.76</td><td headers="hd_h_niceng217er9.tab11_1_1_1_6 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">BNF (drug tariff price)</td></tr><tr><td headers="hd_h_niceng217er9.tab11_1_1_1_1 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intranasal</td><td headers="hd_h_niceng217er9.tab11_1_1_1_2 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Solution for infusion</p>
|
|
<p>50mg/50ml</p>
|
|
<p>1 vial</p>
|
|
</td><td headers="hd_h_niceng217er9.tab11_1_1_1_3 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£9.56</td><td headers="hd_h_niceng217er9.tab11_1_1_1_4 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10mg</td><td headers="hd_h_niceng217er9.tab11_1_1_1_5 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£1.91</td><td headers="hd_h_niceng217er9.tab11_1_1_1_6 hd_b_niceng217er9.tab11_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">BNF (NHS indicative price)<sup>(c)</sup></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Source: BNF Drug Tariff price (NHS indicative price where drug tariff price isn’t reported), 21/02/20<a class="bibr" href="#niceng217er9.ref23" rid="niceng217er9.ref23"><sup>23</sup></a>.</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Sources of doses from the review.</p></div></dd></dl><dl class="bkr_refwrap"><dt>(a)</dt><dd><div id="niceng217er9.tab11_1"><p class="no_margin">No drug tariff price was available for this formulation</p></div></dd></dl><dl class="bkr_refwrap"><dt>(b)</dt><dd><div id="niceng217er9.tab11_2"><p class="no_margin">There are only branded products available for this formulation on the BNF</p></div></dd></dl><dl class="bkr_refwrap"><dt>(c)</dt><dd><div id="niceng217er9.tab11_3"><p class="no_margin">The lowest of two indicative prices for this dose.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab12"><div id="niceng217er9.tab12" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab12/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab12_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Equipment</th><th id="hd_h_niceng217er9.tab12_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost per person</th><th id="hd_h_niceng217er9.tab12_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Source</th></tr></thead><tbody><tr><th headers="hd_h_niceng217er9.tab12_1_1_1_1 hd_h_niceng217er9.tab12_1_1_1_2 hd_h_niceng217er9.tab12_1_1_1_3" id="hd_b_niceng217er9.tab12_1_1_1_1" colspan="3" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<i>Intravenous administration</i>
|
|
</th></tr><tr><td headers="hd_h_niceng217er9.tab12_1_1_1_1 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1 × Cannula (Venflon)</td><td headers="hd_h_niceng217er9.tab12_1_1_1_2 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.86</td><td headers="hd_h_niceng217er9.tab12_1_1_1_3 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="6" colspan="1" style="text-align:left;vertical-align:top;">NHS Supply Chain 2018</td></tr><tr><td headers="hd_h_niceng217er9.tab12_1_1_1_1 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2 × 10ml syringe</td><td headers="hd_h_niceng217er9.tab12_1_1_1_2 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.45</td></tr><tr><td headers="hd_h_niceng217er9.tab12_1_1_1_1 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1 × syringe bung</td><td headers="hd_h_niceng217er9.tab12_1_1_1_2 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.51</td></tr><tr><td headers="hd_h_niceng217er9.tab12_1_1_1_1 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1 × Cliniwipe Disinfectant Wipe</td><td headers="hd_h_niceng217er9.tab12_1_1_1_2 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.02</td></tr><tr><td headers="hd_h_niceng217er9.tab12_1_1_1_1 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1 × IV dressing</td><td headers="hd_h_niceng217er9.tab12_1_1_1_2 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.90</td></tr><tr><td headers="hd_h_niceng217er9.tab12_1_1_1_1 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1 × drawing up needle</td><td headers="hd_h_niceng217er9.tab12_1_1_1_2 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.45</td></tr><tr><td headers="hd_h_niceng217er9.tab12_1_1_1_1 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1 × Sodium chloride 0.9%</td><td headers="hd_h_niceng217er9.tab12_1_1_1_2 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.04</td><td headers="hd_h_niceng217er9.tab12_1_1_1_3 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Electronic Market Information Tool (eMIT)</td></tr><tr><td headers="hd_h_niceng217er9.tab12_1_1_1_1 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Total cost</b>
|
|
</td><td headers="hd_h_niceng217er9.tab12_1_1_1_2 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>£3.23</b>
|
|
</td><td headers="hd_h_niceng217er9.tab12_1_1_1_3 hd_b_niceng217er9.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Source: NHS supply chain<a class="bibr" href="#niceng217er9.ref142" rid="niceng217er9.ref142"><sup>142</sup></a>and Electronic Market Information Tool (eMIT)<a class="bibr" href="#niceng217er9.ref45" rid="niceng217er9.ref45"><sup>45</sup></a></p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab13"><div id="niceng217er9.tab13" class="table"><h3><span class="label">Table 12</span><span class="title">PICO characteristics of review question</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab13/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab13_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng217er9.tab13_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng217er9.tab13_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Inclusion: Children, young people and adults with status epilepticus (convulsive and non-convulsive) who are non-responsive to first line therapy.</p>
|
|
<p>Strata:</p>
|
|
<p>Convulsive status epilepticus</p>
|
|
<p>Non-convulsive status epilepticus (focal vs myoclonic vs absence)</p>
|
|
<p>Exclusion: New-born babies (under 28 days) with acute symptomatic seizures</p>
|
|
</td></tr><tr><th id="hd_b_niceng217er9.tab13_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Interventions</th><td headers="hd_b_niceng217er9.tab13_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Brivaracetam</p>
|
|
<p>Carbamazepine (for focal motor status)</p>
|
|
<p>Chlormethiazole (clomethiazole)</p>
|
|
<p>Clobazam</p>
|
|
<p>Clonazepam (for myoclonic status)</p>
|
|
<p>Chloral hydrate</p>
|
|
<p>Diazepam</p>
|
|
<p>Eslicarbazepine</p>
|
|
<p>Fosphenytoin</p>
|
|
<p>General anaesthetic induction agents</p>
|
|
<p>Immunotherapy</p>
|
|
<p>Intravenous immunoglobulin</p>
|
|
<p>Lacosamide</p>
|
|
<p>Levetiracetam</p>
|
|
<p>Lorazepam</p>
|
|
<p>Midazolam</p>
|
|
<p>Oxcarbazepine</p>
|
|
<p>Oxygen</p>
|
|
<p>Paraldehyde</p>
|
|
<p>Perampanel</p>
|
|
<p>Phenobarbital (phenobarbitone)</p>
|
|
<p>Phenytoin</p>
|
|
<p>Rufinamide</p>
|
|
<p>Stiripentol</p>
|
|
<p>Steroids (methylprednisolone, prednisolone)</p>
|
|
<p>Topiramate</p>
|
|
<p>Valproate (sodium valproate / valproic acid)</p>
|
|
<p>Zonisamide</p>
|
|
<p>Dose according to prescriber discretion and / or local protocols</p>
|
|
</td></tr><tr><th id="hd_b_niceng217er9.tab13_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparisons</th><td headers="hd_b_niceng217er9.tab13_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>One add-on drug vs monotherapy</div></li><li class="half_rhythm"><div>One add-on drug vs different add-on drug</div></li><li class="half_rhythm"><div>Add-on drug vs failure on initial therapeutic management (for example 2 drugs previously administered)</div></li></ul></td></tr><tr><th id="hd_b_niceng217er9.tab13_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_niceng217er9.tab13_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>mortality (including SUDEP)</div></li><li class="half_rhythm"><div>time to seizure cessation, (5 min after drug administration, 10 min, 30 min, 60 min, less than or equal to 24 hours (convulsive), up to 1 month (non-convulsive))</div></li><li class="half_rhythm"><div>time to event seizure cessation</div></li><li class="half_rhythm"><div>seizure recurrence greater than or less than 24 hours after administration of monotherapy</div></li><li class="half_rhythm"><div>time to seizure recurrence after administration of monotherapy</div></li><li class="half_rhythm"><div>quality of life (QOLIE-31, QOLIE-AD-48)</div></li><li class="half_rhythm"><div>length of ICU stay</div></li><li class="half_rhythm"><div>length of hospital stay</div></li><li class="half_rhythm"><div>mean Glasgow outcome scale (% difference in the means between the two groups)</div></li><li class="half_rhythm"><div>adverse events
|
|
<ul class="circle"><li class="half_rhythm"><div>respiratory depression</div></li><li class="half_rhythm"><div>hypotension</div></li><li class="half_rhythm"><div>frequency of endotracheal intubation</div></li><li class="half_rhythm"><div>ICU admission</div></li><li class="half_rhythm"><div>Neuropsychological events such as confusion, anxiety, challenging behaviour, mood disturbance</div></li></ul></div></li><li class="half_rhythm"><div>healthcare resource use</div></li></ul></td></tr><tr><th id="hd_b_niceng217er9.tab13_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_niceng217er9.tab13_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p><ul><li class="half_rhythm"><div>RCTs</div></li><li class="half_rhythm"><div>Systematic reviews of RCTs</div></li></ul>
|
|
Exclusion: Non-English publications, non-randomised studies, conference abstracts</p>
|
|
<p>It is anticipated that there will be sufficient RCT evidence that there is no need to search for non-randomised studies.</p>
|
|
</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab14"><div id="niceng217er9.tab14" class="table"><h3><span class="label">Table 13</span><span class="title">Summary of studies included in the evidence review</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab14/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab14_lrgtbl__"><table><thead><tr><th id="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Intervention</th><th id="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Comparison</th><th id="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">
|
|
<p>Population: Age</p>
|
|
<p>Top 3 reasons for SE</p>
|
|
</th><th id="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Agarwal 2007<a class="bibr" href="#niceng217er9.ref4" rid="niceng217er9.ref4"><sup>4</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous valproic acid: 20 mg/kg as loading dose at a rate of 40 mg/min</p>
|
|
<p>n=50</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous phenytoin: 20 mg/kg at 2 mg/min</p>
|
|
<p>n=50</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Valproic acid: 27.4 (16.8) years</p>
|
|
<p>Antiepileptic drug withdrawal / noncompliance: 24%</p>
|
|
<p>Inflammatory granuloma (neurocysticercosis / tuberculoma: 24%</p>
|
|
<p>CNS infection: 20%</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Phenytoin: 27 (15.1) years</p>
|
|
<p>Antiepileptic drug withdrawal / noncompliance: 28%</p>
|
|
<p>Inflammatory granuloma (neurocysticercosis / tuberculoma: 24%</p>
|
|
<p>CNS infection: 24%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at 7 days</p>
|
|
<p>Cessation of SE within 20 min</p>
|
|
<p>Seizure recurrence within 24 hours</p>
|
|
<p>Hypotension</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ED/ICU</p>
|
|
<p>All patients given intravenous diazepam in doses of 0.2 mg/kg at 2 mg/min up to a maximum of 20 mg before being labelled as refractory</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Amir-Nikpour 2018<a class="bibr" href="#niceng217er9.ref8" rid="niceng217er9.ref8"><sup>8</sup></a></p>
|
|
<p>Iran</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous sodium valproate:</p>
|
|
<p>30 mg/kg as the loading dose then 4-8 mg/kg every 8 hours as maintenance therapy</p>
|
|
<p>n=55</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous phenytoin: 20 mg as loading dose at 2 mg/min up to a maximum of 20 mg</p>
|
|
<p>n=55</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Sodium valproate: 42.16 (15.94) years</p>
|
|
<p>Drug withdrawal: 35%</p>
|
|
<p>Primary generalised seizures: 18%</p>
|
|
<p>Brain stroke: 15%</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Phenytoin: 43.69 (17.60) years</p>
|
|
<p>Drug withdrawal: 33%</p>
|
|
<p>Primary generalised seizures: 18%</p>
|
|
<p>Brain stroke: 13%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at 7 days</p>
|
|
<p>Cessation of SE within 7 days</p>
|
|
<p>Hypotension</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ED</p>
|
|
<p>All patients had been treated with intravenous diazepam in doses of 0.2 mg/kg at 2mg/min up to a maximum of 20 mg before being labelled as refractory</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Chakravarthi 2015<a class="bibr" href="#niceng217er9.ref36" rid="niceng217er9.ref36"><sup>36</sup></a><sup>,</sup>
|
|
<a class="bibr" href="#niceng217er9.ref37" rid="niceng217er9.ref37"><sup>37</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous levetiracetam: loading dose of 20 mg/kg at a rate of 100 mg/min</p>
|
|
<p>n=22</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous phenytoin: 20 mg at a maximum rate of 50 mg/min</p>
|
|
<p>n=22</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>35.41 (16.03) years</p>
|
|
<p>Levetiracetam</p>
|
|
<p>Remote symptomatic: 55%</p>
|
|
<p>Idiopathic: 32%</p>
|
|
<p>Acute symptomatic: 14%</p>
|
|
<p>Phenytoin</p>
|
|
<p>Remote symptomatic: 45%</p>
|
|
<p>Idiopathic: 27%</p>
|
|
<p>Acute symptomatic: 27%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality during hospital stay (no further details given)</p>
|
|
<p>Cessation of SE within 30 min</p>
|
|
<p>Mean duration of SE of good responders</p>
|
|
<p>Recurrence of seizure within 24 hours</p>
|
|
<p>Good outcome at discharge: functional independence measure</p>
|
|
<p>Length of hospital stay</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ED</p>
|
|
<p>All patients had been treated with intravenous lorazepam 0.1 mg/kg at 1 mg/min before being labelled as refractory</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Chen 2011<a class="bibr" href="#niceng217er9.ref42" rid="niceng217er9.ref42"><sup>42</sup></a></p>
|
|
<p>China</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous sodium valproate: initial bolus of 30 mg/kg at a rate of 6 mg/kg/hour as maintenance dose follows by a continuous infusion at a rate of 1-2 mg/kg per hour, infusion maintained for at least 6 hours after the control of last seizure then gradually tapered over 24 hours</p>
|
|
<p>n=30</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous diazepam (3<sup>rd</sup> dose): initial bolus of 0.2 mg/kg at a rate of 5 mg/min followed by a continuous infusion at a rate of 4 mg per hour, rate was maintained for 3 min then decreased every 3 min by 1 µg/kg/min until seizures were controlled or a maximum duration of 1 hour</p>
|
|
<p>n=36</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Young adults and adults</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>41 (21) years</p>
|
|
<p>Valproate</p>
|
|
<p>Epilepsy related: 33%</p>
|
|
<p>Viral encephalitis: 40%</p>
|
|
<p>CVD: 17%</p>
|
|
<p>Diazepam</p>
|
|
<p>Epilepsy related: 36%</p>
|
|
<p>Viral encephalitis: 28%</p>
|
|
<p>CVD: 14%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at hospital discharge (no further details given)</p>
|
|
<p>Cessation of SE within 1 hour and no recurrence within 6 hours</p>
|
|
<p>Recurrence of seizure within 24 hours</p>
|
|
<p>Hypotension</p>
|
|
<p>Need for intubation</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ED</p>
|
|
<p>All patients had been treated with intravenous diazepam 0.2 mg/kg twice in a 10 min period</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Chitsaz 2013<a class="bibr" href="#niceng217er9.ref43" rid="niceng217er9.ref43"><sup>43</sup></a></p>
|
|
<p>Iran</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous sodium valproate: initial bolus of 20 mg/kg infused within 10 min, and half an hour after this loading, continuous infusion at a rate of 1 mg/kg/hour as maintenance dose within 24 hours</p>
|
|
<p>n=15</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous phenytoin: initial bolus of 20 mg/kg and at a rate of 50 mg/min (25 mg/min for older patients), then maintenance dose of 4.5 mg/kg/h for 24 hours</p>
|
|
<p>n=15</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Young adults and adults</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>46.5 (18.7) years</p>
|
|
<p>Patients had intractable epilepsy</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 12 hours</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ED</p>
|
|
<p>All patients had been treated with intravenous diazepam in doses of 0.15 mg/kg at 5 mg/min, if seizure remained uncontrolled at 1 min, then diazepam was administered again, if seizure remained patients were labelled as refractory</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ConSEPT 2009<a class="bibr" href="#niceng217er9.ref46" rid="niceng217er9.ref46"><sup>46</sup></a><sup>,</sup>
|
|
<a class="bibr" href="#niceng217er9.ref47" rid="niceng217er9.ref47"><sup>47</sup></a></p>
|
|
<p>Australia</p>
|
|
<p>New Zealand</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous/intraosseous phenytoin: 20 mg/kg infusion over 20 min (50 mg/ml phenytoin; 0.9% sodium chloride to a maximum volume of 20 ml)</p>
|
|
<p>n=114</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous/intraosseous levetiracetam: 40 mg/kg infusion over 20 min (maximum 1 g, diluted 1.4 with 0.9% sodium chloride to a maximum of 20 ml)</p>
|
|
<p>n=119</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>3.9 (3.8) years</p>
|
|
<p>Phenytoin</p>
|
|
<p>Febrile: 72%</p>
|
|
<p>Focal onset:12%</p>
|
|
<p>Levetiracetam</p>
|
|
<p>Febrile: 73%</p>
|
|
<p>Focal onset:12%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at 3 months</p>
|
|
<p>Cessation of seizure within 5 min</p>
|
|
<p>Cessation of seizure within 2 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ED</p>
|
|
<p>All patients initially treated 2 doses of benzodiazepines</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ESSET 2019<a class="bibr" href="#niceng217er9.ref75" rid="niceng217er9.ref75"><sup>75</sup></a></p>
|
|
<p>USA</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous fosphenytoin: weight-based infusion rate provided fosphenytoin at a dose of 20 mgPE per kilogram (maximum, 1500 mgPE)</p>
|
|
<p>n=118</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous levetiracetam: weight-based infusion rate provided levetiracetam at a dose of 60 mg per kilogram (maximum, 4500 mg)</p>
|
|
<p>n=145</p>
|
|
<p>Intravenous valproate: weight-based infusion rate provided valproate at a dose of 40 mg per kilogram (maximum, 3000 mg)</p>
|
|
<p>n=121</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults and children</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Fosphenytoin: 32.8 (25.4) years</p>
|
|
<p>Seizure or status epilepticus: 88.1%</p>
|
|
<p>Non-epileptic spell: 9.3%</p>
|
|
<p>Unable to adjudicate: 2.5%</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Levetiracetam: 33.3 (26) years</p>
|
|
<p>Seizure or status epilepticus: 88.3%</p>
|
|
<p>Non-epileptic spell: 9.0%</p>
|
|
<p>Unable to adjudicate: 2.8%</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Valproate: 32.2 (25.4) years</p>
|
|
<p>Seizure or status epilepticus: 84.3%</p>
|
|
<p>Non-epileptic spell: 10.7%</p>
|
|
<p>Unable to adjudicate: 5.0%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at end of participation in trial (no further details given)</p>
|
|
<p>Cessation of SE within 1 hour</p>
|
|
<p>Seizure recurrence within 24 hours</p>
|
|
<p>ICU admission</p>
|
|
<p>Hypotension</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>57 EDs</p>
|
|
<p>All patients were refractory to generally accepted cumulative dose of benzodiazepines for seizures lasting more than 5 min, and continued to have persistent or recurrent convulsions in the ED at least 5 min after the last dose of benzodiazepine (to provide sufficient time for the drug at this dose to act) and no more than 30 min after the last dose of benzodiazepine. The minimal adequate cumulative doses of benzodiazepines were defined as diazepam at a dose of 10 mg (administered intravenously or rectally), lorazepam at a dose of 4 mg (administered intravenously), or midazolam at a dose of 10 mg (administered intravenously or intramuscularly) for all adults and for children with a body weight of at least 32 kg; and diazepam at a dose of 0.3 mg of body weight/kg (administered intravenously or rectally), lorazepam at a dose of 0.1 mg/kg (administered intravenously), or midazolam at a dose of 0.3 mg/kg (administered intramuscularly) or 0.2 mg/kg (administered intravenously) for children who weighed less than 32 kg, these drugs may have been administered in divided doses, including before the patient’s arrival in the ED</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Fallah 2007<a class="bibr" href="#niceng217er9.ref55" rid="niceng217er9.ref55"><sup>55</sup></a></p>
|
|
<p>Iran</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous lignocaine: initial dose of 1 mg/kg intravenously at a rate of 25 mg/min, a second bolus of 1 mg/kg was infused if no response or seizure recurred, if seizures did not stop after 2<sup>nd</sup> dose and within 15 min, continuous lignocaine infusion of 1 mg/kg/hour, if still ineffective, lignocaine was infused with the same dose and then decreased by 0.5 mg/kg every hour until cessation</p>
|
|
<p>n=10</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous midazolam: initial bolus of 0.15 mg/kg followed by continuous intravenous infusion of 1 µg/kg/min, with an increase of 1 µg/kg/min every 15 min until control of seizure or maximum dose 6 µg/kg/min was reached, if drug was ineffective at controlling the seizure, it was infused at the same dose for 24 hours, then decreased by 1 µg/kg/min every 2 hours until cessation</p>
|
|
<p>n=10</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age: mean (range)</p>
|
|
<p>3.8 (0.1 to 12) years)</p>
|
|
<p>Lignocaine</p>
|
|
<p>Symptomatic epilepsy: 80%, idiopathic epilepsy: 20%</p>
|
|
<p>Midazolam</p>
|
|
<p>Symptomatic epilepsy: 90%, idiopathic epilepsy: 10%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Cessation of SE</p>
|
|
<p>Length of ICU stay</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ICU</p>
|
|
<p>All patients initially treated with a bolus of intravenous diazepam (0.2 to 0.3 mg/kg) which was repeated after 5 if seizure reoccurred, this was followed by phenytoin (15 to 20 mg/kg over 20 min, if seizures continued, phenobarbitone (10 mg/kg) was intravenously administered over 20 min, if seizure recurred patients were labelled as refractory</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Gujjar 2017<a class="bibr" href="#niceng217er9.ref63" rid="niceng217er9.ref63"><sup>63</sup></a></p>
|
|
<p>Oman</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous levetiracetam: 30 mg/kg over 30 min</p>
|
|
<p>Maintenance treatment of 1 to 1.5 g bid, starting 12 hours after first dose</p>
|
|
<p>n=22</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous phenytoin: 20 mg/kg at a maximum rate of 50 mg/min</p>
|
|
<p>Maintenance treatment of 300 mg/day 24 after initial dose</p>
|
|
<p>n=30</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>37.8 (18) years</p>
|
|
<p>Levetiracetam</p>
|
|
<p>Epilepsy: 50%</p>
|
|
<p>Remote symptoms: 36%:</p>
|
|
<p>Acute symptoms: 14%</p>
|
|
<p>Phenytoin</p>
|
|
<p>Epilepsy: 60%</p>
|
|
<p>Remote symptoms: 27%</p>
|
|
<p>Acute symptoms: 17%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality during hospital stay (no further details given)</p>
|
|
<p>Cessation of SE within 24 hours</p>
|
|
<p>Good outcome at discharge mRS score</p>
|
|
<p>Hypotension</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ED/high-dependence unit/ICU</p>
|
|
<p>All patients received lorazepam (4 mg) or diazepam (5-10 mg) over 2 min, if seizure persisted patients were labelled as refractory</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ECLIPSE 2019<a class="bibr" href="#niceng217er9.ref106" rid="niceng217er9.ref106"><sup>106</sup></a><sup>,</sup>
|
|
<a class="bibr" href="#niceng217er9.ref107" rid="niceng217er9.ref107"><sup>107</sup></a></p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous levetiracetam: administered over 5 min in a dose of 40 mg/kg (maximum dose 2·5 g)</p>
|
|
<p>n=212</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous phenytoin: administered over a minimum of 20 min in a dose of 20 mg/kg (maximum dose 2 g and with a maximum infusion rate of 1 mg/kg per min)</p>
|
|
<p>n=192</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age: median (IQR)</p>
|
|
<p>Levetiracetam: 7 (1.3 to 5.9) years</p>
|
|
<p>Febrile convulsion: 41%</p>
|
|
<p>Seizure (pre-existing epilepsy): 30%</p>
|
|
<p>First afebrile seizure: 11%</p>
|
|
<p>Age: median (IQR)</p>
|
|
<p>Phenytoin: 2.7 (1.6 to 5.6) years</p>
|
|
<p>Febrile convulsion: 43%</p>
|
|
<p>Seizure (pre-existing epilepsy): 34%</p>
|
|
<p>First afebrile seizure: 9%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at 14 days</p>
|
|
<p>Admission to critical care</p>
|
|
<p>Confusion</p>
|
|
<p>Hypotension</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ED</p>
|
|
<p>Inclusion stated children that required second line treatment were eligible</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Handral 2020<a class="bibr" href="#niceng217er9.ref65" rid="niceng217er9.ref65"><sup>65</sup></a></td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Levetiracetam: intravenous Levetiracetam 30 mg/kg over 10 min.</p>
|
|
<p>n=58</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Fosphenytoin: Fosphenytoin infusion 30 mg/kg over 20 min.</p>
|
|
<p>n=58</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age - Mean (SD): LEV: 3.09+2.98; FHP: 3.77+3.79.</p>
|
|
<p>LEV:</p>
|
|
<p>Generalized 75.9%</p>
|
|
<p>Partial seizures: 24.1%</p>
|
|
<p>FHP:</p>
|
|
<p>Generalized seizures: 81%</p>
|
|
<p>Partial: 19%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Cessation of seizure from 10 – 20 minutes</p>
|
|
<p>Seizure recurrence in 48 hours</p>
|
|
<p>Bradycardia</p>
|
|
<p>Tracheal intubation</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>emergency department in a tertiary care hospital</p>
|
|
<p>The study group included all the children who presented with SE in the age group from 1 month to 18 years and did not respond to two doses of lorazepam 0.1 mg/kg/dose.</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Malamiri 2012<a class="bibr" href="#niceng217er9.ref111" rid="niceng217er9.ref111"><sup>111</sup></a></p>
|
|
<p>Iran</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous sodium valproate given at loading dose of 20 mg/kg, diluted in 20 ml saline, at a maximum rate of 5-6 mg/kg per minute over 5-10 min via an infusion pump, the sodium maintenance dose was continuous infusion pf 1 mg/kg per hour, given 60 min after the bolus dose</p>
|
|
<p>n=30</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intravenous Phenobarbital: given at a loading dose of 20 mg/kg via an infusion pump at a rate not faster than 60-100 mg/min.</p>
|
|
<p>n=30</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age: median (range)</p>
|
|
<p>Sodium valproate: 5 (3 to 16) years</p>
|
|
<p>Remote symptomatic epilepsy: 70%</p>
|
|
<p>Idiopathic epilepsy: 13%</p>
|
|
<p>Prolonged febrile seizures: 17%</p>
|
|
<p>Age: median (range)</p>
|
|
<p>Phenobarbital: 4 (3 to 11) years</p>
|
|
<p>Prolonged febrile seizures: 34%</p>
|
|
<p>Idiopathic epilepsy: 23%</p>
|
|
<p>Remote symptomatic epilepsy: 43%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Seizure control within 20 min</p>
|
|
<p>Recurrence of seizure within 24 hours</p>
|
|
<p>Hypotension</p>
|
|
<p>Transient depressed respiration</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Two major university paediatric hospitals</p>
|
|
<p>All patients whose seizures were not controlled by a bolus of IV diazepam (0.2 mg/kg) within 5 min</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Masapu 2018<a class="bibr" href="#niceng217er9.ref113" rid="niceng217er9.ref113"><sup>113</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Propofol: started at a plasma concentration of 1.0 µg/ml and escalated based on seizure response</p>
|
|
<p>n=12</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Midazolam: administered as a bolus of 0.05 mg/kg followed by an infusion</p>
|
|
<p>n=12</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults</p>
|
|
<p>Age: mean (range)</p>
|
|
<p>Propofol: 49 (30 to 65) years</p>
|
|
<p>Generalised tonic-clonic seizures: 45.5%</p>
|
|
<p>Complex partial seizures: 55.5%</p>
|
|
<p>Age: mean (range)</p>
|
|
<p>Midazolam: 45 (26.75 to 48.5) years</p>
|
|
<p>Generalised tonic-clonic seizures: 25%</p>
|
|
<p>Complex partial seizures: 66.7%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality during therapy</p>
|
|
<p>Cessation of SE for 48 hours</p>
|
|
<p>Hypotension</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>ED</p>
|
|
<p>All patients unresponsive to the first line IV lorazepam (0.1 mg/kg) and any two of the second-line IV antiepileptic drugs (phenytoin [15 mg/kg], valproate [20–25 mg/kg], and levetiracetam [30 mg/kg]) were included in the study</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mehta 2007<a class="bibr" href="#niceng217er9.ref120" rid="niceng217er9.ref120"><sup>120</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Valproate: given as an initial loading bolus of 30 mg/kg diluted 1:1 in normal saline from 2 to 5 min</p>
|
|
<p>n=20</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Diazepam: infusion was started at a rate of 10 µg/kg/min and was increased every 5 min by 10 µg/kg/min until status was controlled or a maximum dose of 100 µg/kg/min was reached</p>
|
|
<p>n=20</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Valproate: 36.3 (32.8) months</p>
|
|
<p>Meningoencephalitis: 45%</p>
|
|
<p>Pyogenic meningitis: 5%</p>
|
|
<p>Central nervous system (tuberculosis): 5%</p>
|
|
<p>Epilepsy: 15%</p>
|
|
<p>Intracranial bleeding; 10%</p>
|
|
<p>Metabolic disorder: 5%</p>
|
|
<p>Others: 15%</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Diazepam: 44.5 (42.8) months</p>
|
|
<p>Meningoencephalitis: 55%</p>
|
|
<p>Pyogenic meningitis: 15%</p>
|
|
<p>Central nervous system (tuberculosis): 5%</p>
|
|
<p>Epilepsy: 5%</p>
|
|
<p>Intracranial bleeding: 5%</p>
|
|
<p>Metabolic disorder: 5%</p>
|
|
<p>Others: 10%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Cessation of SE within 30 min</p>
|
|
<p>Time for seizure cessation after drug administration</p>
|
|
<p>ICU admission</p>
|
|
<p>Hypotension</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Emergency and Neurology wards of the Advanced Paediatric Centre</p>
|
|
<p>Patients in whom seizures were not controlled after a bolus of diazepam (0.2 mg/kg) followed by phenytoin (20 mg/kg in normal saline infusion) and a repeat dose of phenytoin (5 to 10 mg/kg in normal saline infusion) 10 min after the first dose were considered to have refractory status epilepticus</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Misra 2017<a class="bibr" href="#niceng217er9.ref122" rid="niceng217er9.ref122"><sup>122</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Valproate: 30 mg/kg was administered intravenously at a rate of 100 mg/min.</p>
|
|
<p>n=33</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Lacosamide: 400 mg intravenously was administered at a rate of 60 mg/min.</p>
|
|
<p>n=33</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults</p>
|
|
<p>Age: median (range)</p>
|
|
<p>Valproate: 40 (18 to 85) years</p>
|
|
<p>CNS infection: 33.3%</p>
|
|
<p>Stroke: 18.2%</p>
|
|
<p>Others: 48.5%</p>
|
|
<p>Age: median (range)</p>
|
|
<p>Lacosamide: 40 (18 to 90) years</p>
|
|
<p>CNS infection: 33.3%</p>
|
|
<p>Stroke: 30.3%</p>
|
|
<p>Others: 36.4%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Time for seizure cessation after drug</p>
|
|
<p>Cessation of SE for 1 hour</p>
|
|
<p>Seizure freedom within 24 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Tertiary care teaching hospital</p>
|
|
<p>Patients received 4 mg lorazepam IV in 10 ml saline in 2 to 4 min, which was repeated after 10 min if seizures were not controlled, those who did not respond to second dose of lorazepam were then randomised</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Noureen 2019<a class="bibr" href="#niceng217er9.ref144" rid="niceng217er9.ref144"><sup>144</sup></a></td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Levetiracetam: a dose of 40 mg/kg (maximum of 500 mg) infused over 15 minutes. The medication was diluted in normal saline. Supportive treatment (e.g., antipyretics and antibiotics) was provided simultaneously to both groups according to the hospital protocol.</p>
|
|
<p>n=300</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Phenytoin: dose was 20 mg/kg (maximum of 250 mg) given over 30 minutes. The medication was diluted in normal saline. Supportive treatment (e.g., antipyretics and antibiotics) was provided simultaneously to both groups according to the hospital protocol.</p>
|
|
<p>n=300</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age: LEV: 3.52±0.24; PHT: 3.46±0.22</p>
|
|
<p>Levetiracetam:</p>
|
|
<p>Meningitis: 40%</p>
|
|
<p>Cerebral palsy & epilepsy: 20%</p>
|
|
<p>Epilepsy:17%</p>
|
|
<p>Phenytoin:</p>
|
|
<p>Meningitis/encephalitis: 43%</p>
|
|
<p>Cerebral palsy & epilepsy: 19%</p>
|
|
<p>Epilepsy: 17%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Time to seizure cessation</p>
|
|
<p>Cardiac depression</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Emergency Department</p>
|
|
<p>Patients with generalized CSE who did not responding to two doses of diazepam (0.2 mg/kg to a maximum of 10 mg, administered 5 minutes apart) were included in the study at 5 minutes after the second dose of diazepam.</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Singhi 2002<a class="bibr" href="#niceng217er9.ref192" rid="niceng217er9.ref192"><sup>192</sup></a></p>
|
|
<p>India</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Midazolam: given a bolus of 0.2 mg/kg followed by a continuous intravenous infusion starting at 2.0 µg/kg until control of the seizure or up to a maximum of 10.0µg/kg/min</p>
|
|
<p>n=21</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Diazepam: the infusion was started at a rate of 0.01 mg/kg/min and was increased every 5 min at a rate of 0.01 mg/kg/min until the seizure was controlled or the maximum dose of 0.1 mg/kg/min was reached</p>
|
|
<p>n=19</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Midazolam: 40.6 (44.3) months</p>
|
|
<p>Meningoencephalitis: 33%</p>
|
|
<p>Bacterial meningitis: 14%</p>
|
|
<p>Late haemorrhagic disease of newborn:19%</p>
|
|
<p>Age: mean (SD)</p>
|
|
<p>Diazepam: 49.6 (43.3) months</p>
|
|
<p>Meningoencephalitis: 53%</p>
|
|
<p>Bacterial meningitis: 16%</p>
|
|
<p>Late haemorrhagic disease of new-born: 0%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality (follow-up not given)</p>
|
|
<p>Time to initial and final seizure cessation</p>
|
|
<p>Cessation of SE within 6 hours</p>
|
|
<p>Seizure recurrence whilst on infusion and after stopping infusion</p>
|
|
<p>Hypotension</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Emergency and Intensive Care Services of the Advance Paediatric Centre</p>
|
|
<p>Patients whose seizures were not controlled after two bolus doses of diazepam (0.3 mg/kg) and phenytoin infusion (20 mg/kg in normal saline infusion over 20 min) followed by a repeat dose of benzodiazepine were considered to have refractory status epilepticus</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Senthil-Kumar 2018<a class="bibr" href="#niceng217er9.ref179" rid="niceng217er9.ref179"><sup>179</sup></a></td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Levetiracetam: 30mg/kg of LEV infusion over 7 minutes diluted 1:1 with 0.9% sodium chloride to a minimum volume of 10ml. Duration administered over 7 minutes.</p>
|
|
<p>n=25</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Intervention 2: Drug - Fosphenytoin. 20mg/kg PE of FPHT diluted 1 in 4 with 0.9% sodium chloride to a minimum volume of 20ml. Duration administered over 7 minutes.</p>
|
|
<p>n=25</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age: mean (SD):</p>
|
|
<p>Levetiracetam: 2.28 + 2.19.</p>
|
|
<p>Fosphenytoin: 3.34 + 3.36</p>
|
|
<p>Levetiracetam: focal seizures: 4%.</p>
|
|
<p>GTCS: 96%</p>
|
|
<p>Fosphenytoin:</p>
|
|
<p>Focal seizures: 4%.</p>
|
|
<p>GTCS: 96%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Cessation of seizure within 5 minutes</p>
|
|
<p>Time taken for seizure cessation</p>
|
|
<p>Length of PICU stay</p>
|
|
<p>Length of hospital stay</p>
|
|
<p>Respiratory depression</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Paediatric emergency Department</p>
|
|
<p>Children with convulsive status epilepticus and who were still seizing after two doses of benzodiazepines (diazepam/ lorazepam/ midazolam) administered by one of the following route (rectal/ buccal/ intranasal/ intravenous/intramuscular) at the recommended dose were included in the study</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Su 2016<a class="bibr" href="#niceng217er9.ref205" rid="niceng217er9.ref205"><sup>205</sup></a></p>
|
|
<p>China</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Phenobarbital: a loading dose of 20 mg/kg (an additional 5–10 mg/kg may be administered) began at a rate of 50 mg/min, followed by an intravenous dose of 100 mg every 6 hours</p>
|
|
<p>n=37</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Valproate: a loading dose of 30 mg/kg (an additional 15 mg/kg may be administered) began at a rate of 3 mg/kg/min, followed by a continuous infusion at a rate of 1–2 mg/kg/hour</p>
|
|
<p>n=36</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults</p>
|
|
<p>Age: mean (SD) 41.72 (17.14) years</p>
|
|
<p>Phenobarbital</p>
|
|
<p>Epilepsy related: 38%</p>
|
|
<p>Virus encephalitis: 38%</p>
|
|
<p>Cerebrovascular disease: 8%</p>
|
|
<p>Valproate</p>
|
|
<p>Epilepsy related: 25%</p>
|
|
<p>Virus encephalitis: 44%</p>
|
|
<p>Cerebrovascular disease: 8%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality at 3 months</p>
|
|
<p>Recurrence of seizure within 24 hours</p>
|
|
<p>Hypotension</p>
|
|
<p>Transient depressed respiration</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Emergency room or neurocritical care unit</p>
|
|
<p>Patients who had not responded to first-line anticonvulsants were enrolled in this trial and were randomized to receive either intravenous phenobarbital or valproate</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Vignesh 2020<a class="bibr" href="#niceng217er9.ref233" rid="niceng217er9.ref233"><sup>233</sup></a></td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Levetiracetam: injection levetiracetam (Levesam, 5 mL per 500 mg, Abbott Ind. Ltd, India) was at a concentration of 5 mg/mL in 0.9% normal saline dilution in the syringe. Patients not responding to intravenous lorazepam received the study drug at the dose of 20 mg kg over 20 minutes as an intravenous infusion.</p>
|
|
<p>n=32</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Phenytoin: phenytoin sodium (Ciroton, 2 mL per 100 mg, Ciron Pharmaceuticals, India) was prepared at a concentration of 5 mg/mL in 0.9% normal saline dilution in the syringe. Patients not responding to intravenous lorazepam received the study drug at the dose of 20 mg/kg over 20 minutes as an intravenous infusion</p>
|
|
<p>n=35</p>
|
|
<p>Valproate (sodium valproate / valproic acid): injection sodium valproate (Valprol, 5 ml per 500 mg, Intas Pharmaceuticals, India) was prepared at a concentration of 5 mg/ml in 0.9% normal saline dilution in the syringe. Patients not responding to intravenous lorazepam received the study drug at the dose of 20 mg kg over 20 minutes as an intravenous infusion.</p>
|
|
<p>n=35</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age - Mean (SD): (months)</p>
|
|
<p>LEV: 58(50).</p>
|
|
<p>PHT: 44(43).</p>
|
|
<p>VAL: 59(44).</p>
|
|
<p>Levetiracetam:</p>
|
|
<p>Acute:44%</p>
|
|
<p>Unknown:34%</p>
|
|
<p>Remote 16%</p>
|
|
<p>Phenytoin:</p>
|
|
<p>Acute: 46%</p>
|
|
<p>Remote:25%</p>
|
|
<p>Unknown:20%</p>
|
|
<p>Valproate:</p>
|
|
<p>Unknown: 48%</p>
|
|
<p>Acute:20%</p>
|
|
<p>Remote:20%</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality</p>
|
|
<p>Time to seizure cessation</p>
|
|
<p>Length of ICU stay</p>
|
|
<p>Length of hospital stay</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Paediatric emergency room</p>
|
|
<p>Children with convulsive status epilepticus</p>
|
|
<p>(clonic, tonic, tonic-clonic, and myoclonic, focal or generalized) not responding to lorazepam were enrolled.</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Wani 2019<a class="bibr" href="#niceng217er9.ref238" rid="niceng217er9.ref238"><sup>238</sup></a></td><td headers="hd_h_niceng217er9.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Levetiracetam: Children in this group 1 were given levetiracetam at a dose of 40 mg/kg diluted in 50 mL of normal saline over 10 min followed by a maintenance dose of 20 mg/kg/day to be given in two divided doses 12 h after initial dose. If seizures recurred after the first loading of the drug, a further additional dose of 10 mg/kg of the same drug was given. If seizures still recurred, the patients were loaded with valproate with a dose of 20 mg/kg dissolved in 50 ml of normal saline over 10 min and further a maintenance dose of 20 mg/kg in two divided doses was given.</p>
|
|
<p>n=52</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Phenytoin: Children in the Phenytoin group were given IV phenytoin as 20 mg/kg diluted in normal saline over 20 min. If seizures recurred after the first loading of the drug, a further additional dose of 10 mg/kg of the same drug was given. If seizures still recurred, the patients were loaded with valproate with a dose of 20 mg/kg dissolved in 50 ml of normal saline over 10 min and further a maintenance dose of 20 mg/kg in two divided dose was given</p>
|
|
<p>n=52</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Children</p>
|
|
<p>Age - Mean (SD):</p>
|
|
<p>LEV:3.39 ± 3.32.</p>
|
|
<p>PHT: 4.80 ± 4.11.</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Time to seizure cessation</p>
|
|
<p>Seizure recurrence</p>
|
|
</td><td headers="hd_h_niceng217er9.tab14_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Tertiary Medical Centre</p>
|
|
<p>Children who came with active seizures were given midazolam at a dose of 0.1 mg/kg slowly followed by IV levetiracetam and phenytoin depending on group allotment. Children with a history of status epilepticus and presently not in active seizure were given only levetiracetam or phenytoin. The subjects were randomized to receive either IV levetiracetam or IV phenytoin.</p>
|
|
</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab15"><div id="niceng217er9.tab15" class="table"><h3><span class="label">Table 14</span><span class="title">Clinical evidence summary: Sodium valproate versus phenytoin</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab15/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab15_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab15_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab15_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab15_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab15_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab15_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab15_1_1_1_5" id="hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Phenytoin</th><th headers="hd_h_niceng217er9.tab15_1_1_1_5" id="hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Valproate (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>280</p>
|
|
<p>(3 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.09</p>
|
|
<p>(0.51 to 2.32)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">79 per 1000</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>7 more per 1000</p>
|
|
<p>(from 39 fewer to 104 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 15 minutes</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>70</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.94</p>
|
|
<p>(0.77 to 1.13)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">886 per 1000</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>53 fewer per 1000</p>
|
|
<p>(from 204 fewer to 115 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 20 min</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>100</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.05</p>
|
|
<p>(0.89 to 1.23)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">840 per 1000</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>42 more per 1000</p>
|
|
<p>(from 92 fewer to 193 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 12 hours</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>30</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.22</p>
|
|
<p>(0.73 to 2.04)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">600 per 1000</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>132 more per 1000</p>
|
|
<p>(from 162 fewer to 624 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 7 days</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>110</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.1</p>
|
|
<p>(0.89 to 1.37)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">709 per 1000</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>71 more per 1000</p>
|
|
<p>(from 78 fewer to 262 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time to seizure cessation (minutes)</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>70</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation (minutes) in the control groups was</p>
|
|
<p>1.4 minutes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation (minutes) in the intervention groups was</p>
|
|
<p>0.20 lower</p>
|
|
<p>(0.81 lower to 0.41 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>100</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.75</p>
|
|
<p>(0.28 to 2)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">160 per 1000</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40 fewer per 1000</p>
|
|
<p>(from 115 fewer to 160 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">PICU admission (days)</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>70</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊕</p>
|
|
<p>HIGH</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean PICU admission (days) in the control groups was</p>
|
|
<p>4 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean PICU admission (days) in the intervention groups was</p>
|
|
<p>6.0 higher</p>
|
|
<p>(4.31 to 7.69 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Length of stay (days)</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>70</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of stay (days) in the control groups was</p>
|
|
<p>6.1 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of stay (days) in the intervention groups was</p>
|
|
<p>0.60 lower</p>
|
|
<p>(2.85 lower to 1.65 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>210</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 0.12</p>
|
|
<p>(0.03 to 0.47)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">86 per 1000</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>90 fewer per 1000</p>
|
|
<p>(from 140 fewer to 30 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Respiratory depression</td><td headers="hd_h_niceng217er9.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>100</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 0.13</p>
|
|
<p>(0.01 to 2.15)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">40 per 1000</td><td headers="hd_h_niceng217er9.tab15_1_1_1_5 hd_h_niceng217er9.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40 fewer per 1000</p>
|
|
<p>(from 110 fewer to 30 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab15_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab15_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab16"><div id="niceng217er9.tab16" class="table"><h3><span class="label">Table 15</span><span class="title">Clinical evidence summary: Levetiracetam versus phenytoin</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab16/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab16_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab16_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab16_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab16_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab16_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab16_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab16_1_1_1_5" id="hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Phenytoin</th><th headers="hd_h_niceng217er9.tab16_1_1_1_5" id="hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Levetiracetam (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>681</p>
|
|
<p>(5 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 0.78</p>
|
|
<p>(0.24 to 2.52)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">21 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>0 fewer per 1000</p>
|
|
<p>(from 30 fewer to 20 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 5 min</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>337</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.88</p>
|
|
<p>(0.74 to 1.05)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">627 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>75 fewer per 1000</p>
|
|
<p>(from 163 fewer to 31 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 5 - 20 minutes</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>104</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.13</p>
|
|
<p>(0.64 to 2.02)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">288 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>37 more per 1000</p>
|
|
<p>(from 104 fewer to 294 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 15 minutes</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊕</p>
|
|
<p>HIGH</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.06</p>
|
|
<p>(0.91 to 1.23)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">886 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>53 more per 1000</p>
|
|
<p>(from 80 fewer to 204 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 20 - 40 minutes</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>104</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1</p>
|
|
<p>(0.06 to 15.57)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">19 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>0 fewer per 1000</p>
|
|
<p>(from 18 fewer to 280 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 30 min</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>644</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.10</p>
|
|
<p>(1.03 to 1.17)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">823 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>82 more per 1000</p>
|
|
<p>(from 25 more to 140 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 2 h</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>233</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.94</p>
|
|
<p>(0.74 to 1.2)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">544 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>33 fewer per 1000</p>
|
|
<p>(from 141 fewer to 109 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 24 h</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>52</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.17</p>
|
|
<p>(0.86 to 1.59)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">700 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>119 more per 1000</p>
|
|
<p>(from 98 fewer to 413 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Recurrence of seizure within 24 h</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>148</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup><sup>,</sup><sup>3</sup></p>
|
|
<p>due to risk of bias, inconsistency, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.46</p>
|
|
<p>(0.24 to 0.87)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">324 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>175 fewer per 1000</p>
|
|
<p>(from 42 fewer to 246 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time to seizure cessation</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation in the control groups was</p>
|
|
<p>3 minutes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation in the intervention groups was</p>
|
|
<p>0.10 higher</p>
|
|
<p>(0.5 lower to 0.7 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean duration of SE of good responders</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>28</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean duration of se of good responders in the intervention groups was</p>
|
|
<p>2.2 higher</p>
|
|
<p>(19.36 lower to 23.76 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Good outcome at discharge (FIM score)</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>44</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.06</p>
|
|
<p>(0.82 to 1.37)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">818 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>49 more per 1000</p>
|
|
<p>(from 147 fewer to 303 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Good outcome at discharge (mRS score)</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>52</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>2</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.36</p>
|
|
<p>(0.76 to 2.44)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">400 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>144 more per 1000</p>
|
|
<p>(from 96 fewer to 576 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean length of hospital stay (days)</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>111</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>2</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of hospital stay (days) in the control groups was</p>
|
|
<p>3.8 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of hospital stay (days) in the intervention groups was</p>
|
|
<p>0.29 higher</p>
|
|
<p>(0.46 lower to 1.05 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean length of PICU admission (days)</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of PICU admission (days) in the control groups was</p>
|
|
<p>4 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of PICU admission (days) in the intervention groups was</p>
|
|
<p>2.0 higher</p>
|
|
<p>(0.49 to 3.51 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Admission to critical care</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>286</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.19</p>
|
|
<p>(0.97 to 1.45)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">537 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>102 more per 1000</p>
|
|
<p>(from 16 fewer to 242 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>314</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.67</p>
|
|
<p>(0.16 to 2.73)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">31 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>10 fewer per 1000</p>
|
|
<p>(from 26 fewer to 54 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events, confusion</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>262</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>OR 7.28</p>
|
|
<p>(0.14 to 366.83)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>10 more per 1000</p>
|
|
<p>(from 10 fewer to 30 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cardiac Depression</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>600</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto 0.13</p>
|
|
<p>(0.01 to 2.16)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">7 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>6 fewer per 1000</p>
|
|
<p>(from 7 fewer to 8 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Respiratory Depression</td><td headers="hd_h_niceng217er9.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>600</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.08</p>
|
|
<p>(0 to 1.36)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">20 per 1000</td><td headers="hd_h_niceng217er9.tab16_1_1_1_5 hd_h_niceng217er9.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>18 fewer per 1000</p>
|
|
<p>(from 20 fewer to 7 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab16_1"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab16_2"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>3</dt><dd><div id="niceng217er9.tab16_3"><p class="no_margin">Downgraded by 1 or 2 increments because: The point estimate varies widely across studies, unexplained by subgroup analysis. The confidence intervals across studies show minimal or no overlap, unexplained by subgroup analysis Heterogeneity, I2=50%, p=0.04, unexplained by subgroup analysis.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab17"><div id="niceng217er9.tab17" class="table"><h3><span class="label">Table 16</span><span class="title">Clinical evidence summary: Lignocaine versus midazolam</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab17/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab17_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab17_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab17_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab17_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab17_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies)</th><th id="hd_h_niceng217er9.tab17_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab17_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab17_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab17_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab17_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab17_1_1_1_5" id="hd_h_niceng217er9.tab17_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Midazolam</th><th headers="hd_h_niceng217er9.tab17_1_1_1_5" id="hd_h_niceng217er9.tab17_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Lignocaine (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab17_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE: children</td><td headers="hd_h_niceng217er9.tab17_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>20</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab17_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab17_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 2.5</p>
|
|
<p>(0.63 to 10)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab17_1_1_1_5 hd_h_niceng217er9.tab17_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">200 per 1000</td><td headers="hd_h_niceng217er9.tab17_1_1_1_5 hd_h_niceng217er9.tab17_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>300 more per 1000</p>
|
|
<p>(from 74 fewer to 1000 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab17_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Length of ICU stay: children</td><td headers="hd_h_niceng217er9.tab17_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>20</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab17_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab17_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab17_1_1_1_5 hd_h_niceng217er9.tab17_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab17_1_1_1_5 hd_h_niceng217er9.tab17_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of ICU stay in the intervention groups was</p>
|
|
<p>4.6 lower</p>
|
|
<p>(8.4 to 0.8 lower)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab17_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intubation needing mechanical ventilation: children</td><td headers="hd_h_niceng217er9.tab17_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>20</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab17_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab17_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.29</p>
|
|
<p>(0.08 to 1.05)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab17_1_1_1_5 hd_h_niceng217er9.tab17_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">700 per 1000</td><td headers="hd_h_niceng217er9.tab17_1_1_1_5 hd_h_niceng217er9.tab17_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>497 fewer per 1000</p>
|
|
<p>(from 644 fewer to 35 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab17_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab17_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab18"><div id="niceng217er9.tab18" class="table"><h3><span class="label">Table 17</span><span class="title">Clinical evidence summary: Sodium valproate versus lacosamide</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab18/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab18_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab18_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab18_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab18_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab18_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies)</th><th id="hd_h_niceng217er9.tab18_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab18_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab18_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab18_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab18_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab18_1_1_1_5" id="hd_h_niceng217er9.tab18_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Lacosamide</th><th headers="hd_h_niceng217er9.tab18_1_1_1_5" id="hd_h_niceng217er9.tab18_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Valproate (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab18_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality: adults</td><td headers="hd_h_niceng217er9.tab18_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>66</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.2</p>
|
|
<p>(0.6 to 2.38)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">303 per 1000</td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>61 more per 1000</p>
|
|
<p>(from 121 fewer to 418 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab18_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time for seizure cessation after drug administration (min) : adults</td><td headers="hd_h_niceng217er9.tab18_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>66</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time for seizure cessation after drug administration (min) in the intervention groups was</p>
|
|
<p>0.61 lower</p>
|
|
<p>(1.81 lower to 0.59 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab18_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE for 1 hour: adults</td><td headers="hd_h_niceng217er9.tab18_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>66</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.1</p>
|
|
<p>(0.78 to 1.54)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">636 per 1000</td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>64 more per 1000</p>
|
|
<p>(from 140 fewer to 344 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab18_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure freedom within 24 hours: adults</td><td headers="hd_h_niceng217er9.tab18_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>66</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.33</p>
|
|
<p>(0.84 to 2.12)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">455 per 1000</td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>150 more per 1000</p>
|
|
<p>(from 73 fewer to 509 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab18_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension: adults</td><td headers="hd_h_niceng217er9.tab18_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>66</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 0.14</p>
|
|
<p>(0 to 6.82)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">30 per 1000</td><td headers="hd_h_niceng217er9.tab18_1_1_1_5 hd_h_niceng217er9.tab18_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>30 fewer per 1000</p>
|
|
<p>(from 110 fewer to 50 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab18_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab18_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab19"><div id="niceng217er9.tab19" class="table"><h3><span class="label">Table 18</span><span class="title">Clinical evidence summary: Midazolam versus diazepam</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab19/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab19_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab19_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab19_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab19_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab19_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab19_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab19_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab19_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab19_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab19_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab19_1_1_1_5" id="hd_h_niceng217er9.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Diazepam</th><th headers="hd_h_niceng217er9.tab19_1_1_1_5" id="hd_h_niceng217er9.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Midazolam (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab19_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality: children</td><td headers="hd_h_niceng217er9.tab19_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 3.62</p>
|
|
<p>(0.87 to 14.97)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">105 per 1000</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>276 more per 1000</p>
|
|
<p>(from 14 fewer to 1000 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab19_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time to initial seizure cessation (min): children</td><td headers="hd_h_niceng217er9.tab19_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to initial seizure cessation (min) in the intervention groups was</p>
|
|
<p>0.1 higher</p>
|
|
<p>(7.04 lower to 7.24 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab19_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time to final seizure cessation (min): children</td><td headers="hd_h_niceng217er9.tab19_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to final seizure cessation (min) in the intervention groups was</p>
|
|
<p>81 higher</p>
|
|
<p>(25.04 lower to 187.04 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab19_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 12 hours (6 hours): children</td><td headers="hd_h_niceng217er9.tab19_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.96</p>
|
|
<p>(0.76 to 1.21)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">895 per 1000</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>36 fewer per 1000</p>
|
|
<p>(from 215 fewer to 188 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab19_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence whilst on infusion: children</td><td headers="hd_h_niceng217er9.tab19_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 3.62</p>
|
|
<p>(1.2 to 10.9)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">158 per 1000</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>414 more per 1000</p>
|
|
<p>(from 32 more to 1000 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab19_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence after stopping infusion: children</td><td headers="hd_h_niceng217er9.tab19_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.21</p>
|
|
<p>(0.31 to 4.71)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">158 per 1000</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>33 more per 1000</p>
|
|
<p>(from 109 fewer to 586 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab19_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension: children</td><td headers="hd_h_niceng217er9.tab19_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.8</p>
|
|
<p>(0.39 to 1.66)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">474 per 1000</td><td headers="hd_h_niceng217er9.tab19_1_1_1_5 hd_h_niceng217er9.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>95 fewer per 1000</p>
|
|
<p>(from 289 fewer to 313 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab19_1"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab20"><div id="niceng217er9.tab20" class="table"><h3><span class="label">Table 19</span><span class="title">Clinical evidence summary: Propofol versus midazolam</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab20/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab20_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab20_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab20_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab20_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab20_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies)</th><th id="hd_h_niceng217er9.tab20_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab20_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab20_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab20_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab20_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab20_1_1_1_5" id="hd_h_niceng217er9.tab20_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Midazolam</th><th headers="hd_h_niceng217er9.tab20_1_1_1_5" id="hd_h_niceng217er9.tab20_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Propofol (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab20_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality: adults</td><td headers="hd_h_niceng217er9.tab20_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>23</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab20_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab20_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.25</p>
|
|
<p>(0.68 to 2.27)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab20_1_1_1_5 hd_h_niceng217er9.tab20_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">583 per 1000</td><td headers="hd_h_niceng217er9.tab20_1_1_1_5 hd_h_niceng217er9.tab20_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>146 more per 1000</p>
|
|
<p>(from 187 fewer to 741 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab20_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE for 48 hours: adults</td><td headers="hd_h_niceng217er9.tab20_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>23</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab20_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab20_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.82</p>
|
|
<p>(0.56 to 5.88)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab20_1_1_1_5 hd_h_niceng217er9.tab20_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">250 per 1000</td><td headers="hd_h_niceng217er9.tab20_1_1_1_5 hd_h_niceng217er9.tab20_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>205 more per 1000</p>
|
|
<p>(from 110 fewer to 1000 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab20_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension: adults</td><td headers="hd_h_niceng217er9.tab20_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>23</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab20_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab20_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 3.27</p>
|
|
<p>(0.4 to 27)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab20_1_1_1_5 hd_h_niceng217er9.tab20_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">83 per 1000</td><td headers="hd_h_niceng217er9.tab20_1_1_1_5 hd_h_niceng217er9.tab20_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>189 more per 1000</p>
|
|
<p>(from 50 fewer to 1000 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab20_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab20_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab21"><div id="niceng217er9.tab21" class="table"><h3><span class="label">Table 20</span><span class="title">Clinical evidence summary: Phenobarbital versus sodium valproate</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab21/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab21_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab21_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab21_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab21_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab21_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies)</th><th id="hd_h_niceng217er9.tab21_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab21_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab21_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab21_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab21_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab21_1_1_1_5" id="hd_h_niceng217er9.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Valproate</th><th headers="hd_h_niceng217er9.tab21_1_1_1_5" id="hd_h_niceng217er9.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Phenobarbital (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab21_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality: adults</td><td headers="hd_h_niceng217er9.tab21_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>73</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.53</p>
|
|
<p>(0.22 to 1.28)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">306 per 1000</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>144 fewer per 1000</p>
|
|
<p>(from 238 fewer to 86 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab21_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure control within 20 min: children</td><td headers="hd_h_niceng217er9.tab21_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>60</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.85</p>
|
|
<p>(0.68 to 1.07)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">900 per 1000</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>135 fewer per 1000</p>
|
|
<p>(from 288 fewer to 63 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab21_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Recurrence of seizure within 24 hours: adults</td><td headers="hd_h_niceng217er9.tab21_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>50</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 3.52</p>
|
|
<p>(1.31 to 9.44)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">148 per 1000</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>373 more per 1000</p>
|
|
<p>(from 46 more to 1000 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab21_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Recurrence of seizure within 24 hours: adults</td><td headers="hd_h_niceng217er9.tab21_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>46</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.21</p>
|
|
<p>(0.05 to 0.98)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">312 per 1000</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>247 fewer per 1000</p>
|
|
<p>(from 6 fewer to 297 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab21_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension: children</td><td headers="hd_h_niceng217er9.tab21_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>60</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 0.14</p>
|
|
<p>(0 to 6.82)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">33 per 1000</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>29 fewer per 1000</p>
|
|
<p>(from 33 fewer to 157 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab21_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension: adults</td><td headers="hd_h_niceng217er9.tab21_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>46</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 0.16</p>
|
|
<p>(0.32 to 0.82)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">312 per 1000</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>245 fewer per 1000</p>
|
|
<p>(from 41 fewer to 186 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab21_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Transient depressed respiration: adults</td><td headers="hd_h_niceng217er9.tab21_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>133</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 8.18</p>
|
|
<p>(1.78 to 37.71)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1000</td><td headers="hd_h_niceng217er9.tab21_1_1_1_5 hd_h_niceng217er9.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>100 more per 1000</p>
|
|
<p>(from 20 more to 190 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab21_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab21_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab22"><div id="niceng217er9.tab22" class="table"><h3><span class="label">Table 21</span><span class="title">Clinical evidence summary: Sodium valproate versus diazepam</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab22/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab22_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab22_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab22_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies)</th><th id="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab22_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab22_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab22_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab22_1_1_1_5" id="hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Diazepam</th><th headers="hd_h_niceng217er9.tab22_1_1_1_5" id="hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Valproate (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality: adults</td><td headers="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 2.92</p>
|
|
<p>(0.61 to 13.96)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">57 per 1000</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>110 more per 1000</p>
|
|
<p>(from 22 fewer to 741 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 30 min: children</td><td headers="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.94</p>
|
|
<p>(0.71 to 1.25)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">850 per 1000</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>51 fewer per 1000</p>
|
|
<p>(from 247 fewer to 213 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 1 hour: adults</td><td headers="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>66</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.9</p>
|
|
<p>(0.57 to 1.43)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">556 per 1000</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>56 fewer per 1000</p>
|
|
<p>(from 239 fewer to 239 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time for seizure cessation after drug administration (min): children</td><td headers="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time for seizure cessation after drug administration (min) in the intervention groups was</p>
|
|
<p>17.8 lower</p>
|
|
<p>(29.94 to 5.66 lower)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Recurrence of seizure within 24 hours: children</td><td headers="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>35</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.8</p>
|
|
<p>(0.23 to 2.83)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">250 per 1000</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>50 fewer per 1000</p>
|
|
<p>(from 192 fewer to 457 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ICU admission: children</td><td headers="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.58</p>
|
|
<p>(0.38 to 0.87)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">950 per 1000</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>399 fewer per 1000</p>
|
|
<p>(from 123 fewer to 589 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension: children and adults</td><td headers="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>106</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">HIGH</td><td headers="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 0.09</p>
|
|
<p>(0.02 to 0.3)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">214 per 1000</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>220 fewer per 1000</p>
|
|
<p>(from 330 fewer to 120 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Respiratory depression: children</td><td headers="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>40</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">HIGH</td><td headers="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 0.06</p>
|
|
<p>(0.02 to 0.23)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">600 per 1000</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>600 fewer per 1000</p>
|
|
<p>(from 820 fewer to 380 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Need for intubation: adults</td><td headers="hd_h_niceng217er9.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>66</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto OR 0.16</p>
|
|
<p>(0.01 to 2.57)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">56 per 1000</td><td headers="hd_h_niceng217er9.tab22_1_1_1_5 hd_h_niceng217er9.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>60 fewer per 1000</p>
|
|
<p>(from 150 fewer to 40 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab22_1"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab23"><div id="niceng217er9.tab23" class="table"><h3><span class="label">Table 22</span><span class="title">Clinical evidence summary: Levetiracetam versus Fosphenytoin</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab23/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab23_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab23_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab23_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab23_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab23_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab23_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab23_1_1_1_5" id="hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Fosphenytoin</th><th headers="hd_h_niceng217er9.tab23_1_1_1_5" id="hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Levetiracetam (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>275</p>
|
|
<p>(1 study)</p>
|
|
<p>30 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.94</p>
|
|
<p>(0.51 to 7.36)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">24 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>23 more per 1000</p>
|
|
<p>(from 12 fewer to 153 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE from 10 - 20 minutes</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>116</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.98</p>
|
|
<p>(0.88 to 1.09)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">931 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>19 fewer per 1000</p>
|
|
<p>(from 112 fewer to 84 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of seizure within 5 minutes</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>50</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.10</p>
|
|
<p>(0.89 to 1.35)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">840 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>84 more per 1000</p>
|
|
<p>(from 92 fewer to 294 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE (and improvement in consciousness at 60 min without other anticonvulsant medications)</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>263</p>
|
|
<p>(1 study)</p>
|
|
<p>60 minutes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.04</p>
|
|
<p>(0.8 to 1.36)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">449 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>18 more per 1000</p>
|
|
<p>(from 90 fewer to 162 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time to seizure cessation</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>50</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation in the control groups was</p>
|
|
<p>2.5 minutes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation in the intervention groups was</p>
|
|
<p>0.80 higher</p>
|
|
<p>(0.09 to 1.51 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours (within 60 mins to 12 hours after start of trial drug infusion)</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>325</p>
|
|
<p>(2 studies)</p>
|
|
<p>60 mins to 12 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.07</p>
|
|
<p>(0.59 to 1.95)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">113 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>8 more per 1000</p>
|
|
<p>(from 46 fewer to 108 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 48 hours</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>116</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.77</p>
|
|
<p>(0.37 to 1.61)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">224 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>52 fewer per 1000</p>
|
|
<p>(from 141 fewer to 137 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Length of hospital stay</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>50</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of hospital stay in the control groups was</p>
|
|
<p>5.8 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of hospital stay in the intervention groups was</p>
|
|
<p>0.50 higher</p>
|
|
<p>(1.91 lower to 2.91 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Length of PICU stay</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>50</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of PICU stay in the control groups was</p>
|
|
<p>42.3 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of PICU stay in the intervention groups was</p>
|
|
<p>1.70 higher</p>
|
|
<p>(25.88 lower to 29.28 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ICU admission</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>263</p>
|
|
<p>(1 study)</p>
|
|
<p>30 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.01</p>
|
|
<p>(0.83 to 1.25)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">593 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>6 more per 1000</p>
|
|
<p>(from 101 fewer to 148 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension (defined as life threatening, within 60 mins after start of trial-drug infusion)</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>275</p>
|
|
<p>(1 study)</p>
|
|
<p>60 minutes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.21</p>
|
|
<p>(0.02 to 1.84)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">32 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>25 fewer per 1000</p>
|
|
<p>(from 31 fewer to 27 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Respiratory depression</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>325</p>
|
|
<p>(2 studies)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.57</p>
|
|
<p>(0.29 to 1.14)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">120 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>52 fewer per 1000</p>
|
|
<p>(from 85 fewer to 17 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bradycardia</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>116</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Peto 0.14</p>
|
|
<p>(0.00 to 6.82)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">17 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>15 fewer per 1000</p>
|
|
<p>(from 17 fewer to 100 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab23_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Tracheal Intubation</td><td headers="hd_h_niceng217er9.tab23_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>116</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.33</p>
|
|
<p>(0.04 to 3.11)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">52 per 1000</td><td headers="hd_h_niceng217er9.tab23_1_1_1_5 hd_h_niceng217er9.tab23_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>35 fewer per 1000</p>
|
|
<p>(from 50 fewer to 109 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab23_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab23_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab24"><div id="niceng217er9.tab24" class="table"><h3><span class="label">Table 23</span><span class="title">Clinical evidence summary: Levetiracetam versus valproate</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab24/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab24_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab24_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab24_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab24_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab24_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab24_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab24_1_1_1_5" id="hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Valproate</th><th headers="hd_h_niceng217er9.tab24_1_1_1_5" id="hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Levetiracetam (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>342</p>
|
|
<p>(2 studies)</p>
|
|
<p>30 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup><sup>,</sup><sup>3</sup></p>
|
|
<p>due to risk of bias, inconsistency, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.94</p>
|
|
<p>(0.53 to 7.1)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">19 per 1000</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>18 more per 1000</p>
|
|
<p>(from 9 fewer to 114 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 15 minutes</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>3</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.13</p>
|
|
<p>(0.95 to 1.35)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">829 per 1000</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>108 more per 1000</p>
|
|
<p>(from 41 fewer to 290 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Time to seizure cessation</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>3</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation in the control groups was</p>
|
|
<p>3.2 minutes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean time to seizure cessation in the intervention groups was</p>
|
|
<p>0.10 lower</p>
|
|
<p>(0.75 lower to 0.55 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE (and improvement in consciousness at 60 min without other anticonvulsant medications)</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>263</p>
|
|
<p>(1 study)</p>
|
|
<p>60 minutes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊝⊝</p>
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>3</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.04</p>
|
|
<p>(0.8 to 1.36)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">449 per 1000</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>18 more per 1000</p>
|
|
<p>(from 90 fewer to 162 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours (within 60 mins to 12 hours after start of trial drug infusion)</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>275</p>
|
|
<p>(1 study)</p>
|
|
<p>60 mins to 12 hours</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>3</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.95</p>
|
|
<p>(0.48 to 1.87)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">112 per 1000</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>6 fewer per 1000</p>
|
|
<p>(from 58 fewer to 97 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Length of hospital stay</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>3</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of hospital stay in the control groups was</p>
|
|
<p>5.5 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of hospital stay in the intervention groups was</p>
|
|
<p>1.50 higher</p>
|
|
<p>(1.63 lower to 4.63 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Length of PICU admission</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>67</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>3</sup></p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of PICU admission in the control groups was</p>
|
|
<p>10 days</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>The mean length of PICU admission in the intervention groups was</p>
|
|
<p>4.0 lower</p>
|
|
<p>(5.97 to 2.03 lower)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ICU admission</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>266</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊝</p>
|
|
<p>MODERATE<sup>1</sup></p>
|
|
<p>due to risk of bias</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.02</p>
|
|
<p>(0.84 to 1.25)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">587 per 1000</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>12 more per 1000</p>
|
|
<p>(from 94 fewer to 147 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension (defined as life threatening, within 60 mins after start of trial-drug infusion)</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>275</p>
|
|
<p>(1 study)</p>
|
|
<p>60 minutes</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>3</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.42</p>
|
|
<p>(0.04 to 4.54)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">16 per 1000</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>9 fewer per 1000</p>
|
|
<p>(from 15 fewer to 57 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab24_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Respiratory depression</td><td headers="hd_h_niceng217er9.tab24_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>275</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>3</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.00</p>
|
|
<p>(0.45 to 2.24)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">80 per 1000</td><td headers="hd_h_niceng217er9.tab24_1_1_1_5 hd_h_niceng217er9.tab24_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>0 fewer per 1000</p>
|
|
<p>(from 44 fewer to 99 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab24_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab24_2"><p class="no_margin">Downgraded by 1 or 2 increments because: The point estimate varies widely across studies, unexplained by subgroup analysis. The confidence intervals across studies show minimal or no overlap, unexplained by subgroup analysis Heterogeneity, I2=50%, p=0.04, unexplained by subgroup analysis.</p></div></dd></dl><dl class="bkr_refwrap"><dt>3</dt><dd><div id="niceng217er9.tab24_3"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab25"><div id="niceng217er9.tab25" class="table"><h3><span class="label">Table 24</span><span class="title">Clinical evidence summary: Fosphenytoin versus valproate</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab25/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab25_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab25_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab25_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng217er9.tab25_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab25_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies)</th><th id="hd_h_niceng217er9.tab25_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab25_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng217er9.tab25_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng217er9.tab25_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng217er9.tab25_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng217er9.tab25_1_1_1_5" id="hd_h_niceng217er9.tab25_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Valproate</th><th headers="hd_h_niceng217er9.tab25_1_1_1_5" id="hd_h_niceng217er9.tab25_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Fosphenytoin (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng217er9.tab25_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mortality: children and adults</td><td headers="hd_h_niceng217er9.tab25_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>250</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.50</p>
|
|
<p>(0.26 to 8.82)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">16 per 1000</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>8 more per 1000</p>
|
|
<p>(from 12 fewer to 125 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab25_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cessation of SE within 60 min: children and adults</td><td headers="hd_h_niceng217er9.tab25_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>239</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 0.97</p>
|
|
<p>(0.74 to 1.28)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">463 per 1000</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>14 fewer per 1000</p>
|
|
<p>(from 120 fewer to 130 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab25_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seizure recurrence within 24 hours: children and adults</td><td headers="hd_h_niceng217er9.tab25_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>250</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.00</p>
|
|
<p>(0.50 to 2.01)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">112 per 1000</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>0 fewer per 1000</p>
|
|
<p>(from 56 fewer to 113 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab25_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ICU admission: children and adults</td><td headers="hd_h_niceng217er9.tab25_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>239</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>2</sup> due to risk of bias</td><td headers="hd_h_niceng217er9.tab25_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RR 1.01</p>
|
|
<p>(0.82 to 1.25)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">587 per 1000</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>6 more per 1000</p>
|
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<p>(from 106 fewer to 147 more)</p>
|
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</td></tr><tr><td headers="hd_h_niceng217er9.tab25_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hypotension: children and adults</td><td headers="hd_h_niceng217er9.tab25_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>250</p>
|
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<p>(1 study)</p>
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</td><td headers="hd_h_niceng217er9.tab25_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>VERY LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
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<p>due to risk of bias, imprecision</p>
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</td><td headers="hd_h_niceng217er9.tab25_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>RR 2.00</p>
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<p>(0.37 to 10.72)</p>
|
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</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">16 per 1000</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>16 more per 1000</p>
|
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<p>(from 10 fewer to 156 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng217er9.tab25_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Respiratory depression: children and adults</td><td headers="hd_h_niceng217er9.tab25_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>250</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>LOW<sup>1</sup><sup>,</sup><sup>2</sup></p>
|
|
<p>due to risk of bias, imprecision</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>RR 1.60</p>
|
|
<p>(0.76 to 3.39)</p>
|
|
</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">80 per 1000</td><td headers="hd_h_niceng217er9.tab25_1_1_1_5 hd_h_niceng217er9.tab25_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>48 more per 1000</p>
|
|
<p>(from 19 fewer to 191 more)</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng217er9.tab25_1"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng217er9.tab25_2"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng217er9tab26"><div id="niceng217er9.tab26" class="table"><h3><span class="label">Table 25</span><span class="title">UK costs of drugs used as add on therapy for Status Epilepticus</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK581143/table/niceng217er9.tab26/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng217er9.tab26_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng217er9.tab26_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Drug</th><th id="hd_h_niceng217er9.tab26_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Description</th><th id="hd_h_niceng217er9.tab26_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost</th><th id="hd_h_niceng217er9.tab26_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Dose</th><th id="hd_h_niceng217er9.tab26_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost per dose</th><th id="hd_h_niceng217er9.tab26_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost source</th></tr></thead><tbody><tr><th headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_h_niceng217er9.tab26_1_1_1_2 hd_h_niceng217er9.tab26_1_1_1_3 hd_h_niceng217er9.tab26_1_1_1_4 hd_h_niceng217er9.tab26_1_1_1_5 hd_h_niceng217er9.tab26_1_1_1_6" id="hd_b_niceng217er9.tab26_1_1_1_1" colspan="6" rowspan="1" style="text-align:left;vertical-align:top;">Sodium valproate</th></tr><tr><td headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_b_niceng217er9.tab26_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Solution for injection</td><td headers="hd_h_niceng217er9.tab26_1_1_1_2 hd_b_niceng217er9.tab26_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>300mg/3ml</p>
|
|
<p>5 ampoules</p>
|
|
</td><td headers="hd_h_niceng217er9.tab26_1_1_1_3 hd_b_niceng217er9.tab26_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£27.49</td><td headers="hd_h_niceng217er9.tab26_1_1_1_4 hd_b_niceng217er9.tab26_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2.8g<sup>(a)</sup></td><td headers="hd_h_niceng217er9.tab26_1_1_1_5 hd_b_niceng217er9.tab26_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£54.98</td><td headers="hd_h_niceng217er9.tab26_1_1_1_6 hd_b_niceng217er9.tab26_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">eMIT</td></tr><tr><th headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_h_niceng217er9.tab26_1_1_1_2 hd_h_niceng217er9.tab26_1_1_1_3 hd_h_niceng217er9.tab26_1_1_1_4 hd_h_niceng217er9.tab26_1_1_1_5 hd_h_niceng217er9.tab26_1_1_1_6" id="hd_b_niceng217er9.tab26_1_1_3_1" colspan="6" rowspan="1" style="text-align:left;vertical-align:top;">Phenytoin</th></tr><tr><td headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_b_niceng217er9.tab26_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Solution for injection</td><td headers="hd_h_niceng217er9.tab26_1_1_1_2 hd_b_niceng217er9.tab26_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>250mg/5ml</p>
|
|
<p>5 ampoules</p>
|
|
</td><td headers="hd_h_niceng217er9.tab26_1_1_1_3 hd_b_niceng217er9.tab26_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£3.37</td><td headers="hd_h_niceng217er9.tab26_1_1_1_4 hd_b_niceng217er9.tab26_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1g</td><td headers="hd_h_niceng217er9.tab26_1_1_1_5 hd_b_niceng217er9.tab26_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£2.69</td><td headers="hd_h_niceng217er9.tab26_1_1_1_6 hd_b_niceng217er9.tab26_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">eMIT</td></tr><tr><th headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_h_niceng217er9.tab26_1_1_1_2 hd_h_niceng217er9.tab26_1_1_1_3 hd_h_niceng217er9.tab26_1_1_1_4 hd_h_niceng217er9.tab26_1_1_1_5 hd_h_niceng217er9.tab26_1_1_1_6" id="hd_b_niceng217er9.tab26_1_1_5_1" colspan="6" rowspan="1" style="text-align:left;vertical-align:top;">Leveritacetam</th></tr><tr><td headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_b_niceng217er9.tab26_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Solution for injection</td><td headers="hd_h_niceng217er9.tab26_1_1_1_2 hd_b_niceng217er9.tab26_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>500mg/5ml</p>
|
|
<p>10 infusion vials</p>
|
|
</td><td headers="hd_h_niceng217er9.tab26_1_1_1_3 hd_b_niceng217er9.tab26_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£28.37</td><td headers="hd_h_niceng217er9.tab26_1_1_1_4 hd_b_niceng217er9.tab26_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2g – 4g</td><td headers="hd_h_niceng217er9.tab26_1_1_1_5 hd_b_niceng217er9.tab26_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£11.35 - £22.69</td><td headers="hd_h_niceng217er9.tab26_1_1_1_6 hd_b_niceng217er9.tab26_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">eMIT</td></tr><tr><th headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_h_niceng217er9.tab26_1_1_1_2 hd_h_niceng217er9.tab26_1_1_1_3 hd_h_niceng217er9.tab26_1_1_1_4 hd_h_niceng217er9.tab26_1_1_1_5 hd_h_niceng217er9.tab26_1_1_1_6" id="hd_b_niceng217er9.tab26_1_1_7_1" colspan="6" rowspan="1" style="text-align:left;vertical-align:top;">Diazepam</th></tr><tr><td headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_b_niceng217er9.tab26_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Solution for injection</td><td headers="hd_h_niceng217er9.tab26_1_1_1_2 hd_b_niceng217er9.tab26_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>10mg/2ml</p>
|
|
<p>10 ampoules</p>
|
|
</td><td headers="hd_h_niceng217er9.tab26_1_1_1_3 hd_b_niceng217er9.tab26_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£3.95</td><td headers="hd_h_niceng217er9.tab26_1_1_1_4 hd_b_niceng217er9.tab26_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10mg<sup>(b)</sup></td><td headers="hd_h_niceng217er9.tab26_1_1_1_5 hd_b_niceng217er9.tab26_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.40</td><td headers="hd_h_niceng217er9.tab26_1_1_1_6 hd_b_niceng217er9.tab26_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">eMIT</td></tr><tr><th headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_h_niceng217er9.tab26_1_1_1_2 hd_h_niceng217er9.tab26_1_1_1_3 hd_h_niceng217er9.tab26_1_1_1_4 hd_h_niceng217er9.tab26_1_1_1_5 hd_h_niceng217er9.tab26_1_1_1_6" id="hd_b_niceng217er9.tab26_1_1_9_1" colspan="6" rowspan="1" style="text-align:left;vertical-align:top;">Buccal midazolam</th></tr><tr><td headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_b_niceng217er9.tab26_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Solution for injection</td><td headers="hd_h_niceng217er9.tab26_1_1_1_2 hd_b_niceng217er9.tab26_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>10mg/5ml</p>
|
|
<p>10 ampoules</p>
|
|
</td><td headers="hd_h_niceng217er9.tab26_1_1_1_3 hd_b_niceng217er9.tab26_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£7.26</td><td headers="hd_h_niceng217er9.tab26_1_1_1_4 hd_b_niceng217er9.tab26_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10mg<sup>(b)</sup></td><td headers="hd_h_niceng217er9.tab26_1_1_1_5 hd_b_niceng217er9.tab26_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.73</td><td headers="hd_h_niceng217er9.tab26_1_1_1_6 hd_b_niceng217er9.tab26_1_1_9_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">BNF</td></tr><tr><th headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_h_niceng217er9.tab26_1_1_1_2 hd_h_niceng217er9.tab26_1_1_1_3 hd_h_niceng217er9.tab26_1_1_1_4 hd_h_niceng217er9.tab26_1_1_1_5 hd_h_niceng217er9.tab26_1_1_1_6" id="hd_b_niceng217er9.tab26_1_1_11_1" colspan="6" rowspan="1" style="text-align:left;vertical-align:top;">Phenobarbital</th></tr><tr><td headers="hd_h_niceng217er9.tab26_1_1_1_1 hd_b_niceng217er9.tab26_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Solution for injection</td><td headers="hd_h_niceng217er9.tab26_1_1_1_2 hd_b_niceng217er9.tab26_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>200mg/1ml</p>
|
|
<p>10 ampoules</p>
|
|
</td><td headers="hd_h_niceng217er9.tab26_1_1_1_3 hd_b_niceng217er9.tab26_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£58.50</td><td headers="hd_h_niceng217er9.tab26_1_1_1_4 hd_b_niceng217er9.tab26_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">700mg</td><td headers="hd_h_niceng217er9.tab26_1_1_1_5 hd_b_niceng217er9.tab26_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£23.40<sup>(c)</sup></td><td headers="hd_h_niceng217er9.tab26_1_1_1_6 hd_b_niceng217er9.tab26_1_1_11_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">eMIT</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Sources: Electronic Market Information Tool (eMIT), 09/01/20<a class="bibr" href="#niceng217er9.ref45" rid="niceng217er9.ref45"><sup>45</sup></a>. British National Formulary (BNF), 13/07/21<a class="bibr" href="#niceng217er9.ref23" rid="niceng217er9.ref23"><sup>23</sup></a></p></div></dd></dl><dl class="bkr_refwrap"><dt>(a)</dt><dd><div id="niceng217er9.tab26_1"><p class="no_margin">Based on the average dose reported in the ESET trial (40mg per kg) and assuming a person weighs on average 70kg<a class="bibr" href="#niceng217er9.ref75" rid="niceng217er9.ref75"><sup>75</sup></a></p></div></dd></dl><dl class="bkr_refwrap"><dt>(b)</dt><dd><div id="niceng217er9.tab26_2"><p class="no_margin">10mg and then an additional 10mg if required. Cost is presented for 10mg</p></div></dd></dl><dl class="bkr_refwrap"><dt>(c)</dt><dd><div id="niceng217er9.tab26_3"><p class="no_margin">Assuming the remainder of the medication cannot be used</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">All other sources of doses from the GC</p></div></dd></dl></dl></div></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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