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首页> 外文期刊>Trials >Emergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial
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Emergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial

机译：儿童癫痫持续状态中左乙拉西坦或苯妥英钠的紧急治疗—EcLiPSE研究：一项随机对照试验的研究方案

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Background Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the family and the health and social care systems. The current recommended first-choice, second-line treatment in children aged 6?months and above is intravenous phenytoin (fosphenytoin in the USA), although there is a lack of evidence for its use and it is associated with significant side effects. Emerging evidence suggests that intravenous levetiracetam may be effective as a second-line agent for CSE, and fewer adverse effects have been described. This trial therefore aims to determine whether intravenous phenytoin or levetiracetam is more effective, and safer, in treating childhood CSE. Methods/design This is a phase IV, multi-centre, parallel group, randomised controlled, open-label trial. Following treatment for CSE with first-line treatment, children with ongoing seizures are randomised to receive either phenytoin (20?mg/kg, maximum 2?g) or levetiracetam (40?mg/kg, maximum 2.5?g) intravenously. The primary outcome measure is the cessation of all visible signs of CSE as determined by the treating clinician. Secondary outcome measures include the need for further anti-seizure medications or rapid sequence induction for ongoing CSE, admission to critical care areas, and serious adverse reactions. Patients are recruited without prior consent, with deferred consent sought at an appropriate time for the family. The primary analysis will be by intention-to-treat. The primary outcome is a time to event outcome and a sample size of 140 participants in each group will have 80% power to detect an increase in CSE cessation rates from 60% to 75%. Our total sample size of 308 randomised and treated participants will allow for 10% loss to follow-up. Discussion This clinical trial will determine whether phenytoin or levetiracetam is more effective as an intravenous second-line agent for CSE, and provide evidence for management recommendations. In addition, this trial will also provide data on which of these therapies is safer in this setting. Trial registration ISRCTN identifier, ISRCTN22567894 . Registered on 27 August 2015 EudraCT identifier, 2014-002188-13 . Registered on 21 May 2014 NIHR HTA Grant: 12/127/134
机译：背景癫痫持续状态（CSE）是儿童期最常见的威胁生命的神经系统紧急情况。这些儿童也有严重发病的危险，对家庭以及健康和社会护理系统有急性和慢性影响。目前推荐的6个月及以上儿童的首选二线治疗方法是静脉注射苯妥英钠（美国的苯妥英钠），尽管尚缺乏使用证据，并且与明显的副作用有关。越来越多的证据表明，静脉注射左乙拉西坦可能作为CSE的二线治疗药物有效，而且不良反应也有所减少。因此，该试验旨在确定静脉注射苯妥英钠或左乙拉西坦在治疗儿童CSE中是否更有效，更安全。方法/设计这是IV期，多中心，平行组，随机对照，开放标签的试验。接受一线治疗的CSE后，持续发作的儿童被随机分配接受苯妥英钠（20？mg / kg，最大2？g）或左乙拉西坦（40？mg / kg，最大2.5？g）静脉注射。主要结局指标是治疗医师确定所有可见的CSE征象停止。次要结局指标包括持续进行CSE的其他抗癫痫药或快速序列诱导药物，进入重症监护区和严重不良反应的需求。征募患者时未事先征得其同意，并在适当的时间寻求家人的同意。主要分析将按意向进行。主要结果是事件发生的时间，每组140名参与者的样本量将具有80％的能力来检测CSE戒断率从60％上升到75％。我们的308名随机和治疗参与者的总样本量将使随访减少10％。讨论该临床试验将确定苯妥英钠或左乙拉西坦作为CSE的静脉二线药物是否更有效，并为管理建议提供证据。此外，该试验还将提供有关在这种情况下哪种疗法更安全的数据。试用注册ISRCTN标识符ISRCTN22567894。 2015年8月27日注册，EudraCT标识符2014-002188-13。 2014年5月21日注册，NIHR HTA资助金：12/127/134

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