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首页> 外文期刊>BMC Pediatrics >A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study
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A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study

机译：左乙拉西坦与苯妥英钠治疗儿童惊厥性癫痫持续状态的多中心随机对照试验（协议）：惊厥性癫痫持续状态小儿试验（ConSEPT）-PREDICT研究

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Background Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. Methods/Design 200 children aged between 3?months and 16?years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40?mg/kg IV levetiracetam infusion over 5?min or 20?mg/kg IV phenytoin infusion over 20?min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. Discussion This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines. Trial registration Prospectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583 (11/2/2015). UTN U1111–1144-5272. ConSEPT protocol version 4 (12/12/2014).
机译：背景惊厥性癫痫持续状态（CSE）是最常见的威胁生命的儿童神经系统紧急情况。尽管如此，目前尚缺乏高质量的证据支持一线苯二氮卓类药物治疗后的药物使用，目前的治疗方案仅基于非实验证据和专家意见。苯妥英钠目前的治疗标准只有60％有效，并伴有相当大的不良反应。新型抗惊厥药左乙拉西坦（levetiracetam）可以更快地给药，可能更有效，并且副作用更可忍受。该方案中提出的研究的主要目的是确定静脉内（IV）左乙拉西坦或IV苯妥英钠是儿童CSE紧急处理的更好的二线治疗方法。方法/设计200名年龄在3个月至16岁之间的儿童向澳大利亚和新西兰的13个急诊科就CSE进行了试验，但未能因一线苯二氮卓类药物而停止治疗，将被纳入该多中心开放随机对照试验。参与者将在5分钟内被随机分配至静脉注射左乙拉西坦40？mg / kg，或在20分钟内被静脉注射苯妥英钠20？mg / kg。该研究的主要结果是在完成研究药物输注后五分钟，癫痫发作活动的临床停止。对主要结果的盲目确认将通过视频记录并由对治疗分配不知情的主要结果评估小组进行评估来进行。次要结果包括：2小时临床停止癫痫发作活动;停止临床癫痫发作的时间;需要快速序列诱导;重症监护室（ICU）入院;严重不良事件;医院/ ICU住院时间;卫生保健费用;出院后一个月的癫痫发作状态/死亡。讨论本文介绍了对苯二氮卓类药物无效的CSE儿童进行左乙拉西坦与苯妥英钠比较的随机对照试验的背景，原理和设计。这项研究将为一线苯二氮卓类药物治疗后的儿科CSE提供首个高质量证据。试验注册已预先在澳大利亚和新西兰临床试验注册中心（ANZCTR）注册：ACTRN12615000129583（11/2/2015）。 UTN U1111–1144-5272。 ConSEPT协议版本4（12/12/2014）。

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