CTRI/2020/01/022641已完成4 期
Efficacy of intravenous levetiracetam versus intravenous phenytoin in management of convulsive status epileptics in children; an open label randomised controlled trial
Dr Pooja Shankar Sawlani1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2020年10月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Intravenous levetiracetam is superior to intravenous phenytoin in control of convulsions in paediatric population
研究概览
简要总结
This study is an open labelled randomised controlled trial to compare efficacy of intravenous levetiracetam 40 mg per kg per min and intravenous phenytoin 20 mg per kg per min in management of convulsive status epileptics in children. The outcome of the study it to provide data that intravenous levetiracetam is superior to intravenous phenytoin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •All children from age of one year to 12 years presenting in status epilepticus not controlled by initial emergent therapy with benzodiazepines as per ILAE Protocol.
排除标准
- •1.Status epilepticus controlled by initial emergent therapy with benzodiazepines.
- •2.Children less than one year of age and >12 years Received loading dose of second-line anticonvulsants (Phenytoin, Phenobarbitone, Valproate, Levetiracetam) for control of current status epilepticus 3.History of Head injury.
- •4.Convulsions due to acute metabolic / electrolyte disturbances.
结局指标
主要结局
Intravenous levetiracetam is superior to intravenous phenytoin in control of convulsions in paediatric population
时间窗: 24 months
次要结局
- To provide data regarding decrease incident of recurrence of convulsion while using intravenous levetiracetam in comparison to intravenous phenytoin(1 day)
研究者
研究点 (1)
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