Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus
研究概览
简要总结
The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.
详细描述
After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus
排除标准
- •children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions
研究组 & 干预措施
Intravenous levetireacetam
Drug:Intravenous levetireacetam will be given at a loading dose of 20-30mg/kg then it will be added in maintainance dose of (5-30mg/kg/day)
干预措施: intravenous levetireacetam (Drug)
intravenous phenytoin
Intravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day
干预措施: intravenous levetireacetam (Drug)
结局指标
主要结局
comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus
时间窗: 48 hours
the intervention will be considered efficacious if child will not have breakthrough fits for 48 hours
次要结局
未报告次要终点
研究者
ayesha tariq
Post graduate resident in Pediatrics medicine(MD Paeds)
King Edward Medical University