Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- cessation of convulsion
研究概览
简要总结
The study will be conducted on 60 children suffering from status epilepticus who will be admitted to Pediatric Neurology Unit and Pediatric ICU of Tanta Hospital University.
详细描述
The aim of this work is to compare the efficacy of Levetireacetam and Phenytoin in management of pediatric status epilepticus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children suffering from convulsive generalized tonic clonic status epilepticus at any age.
排除标准
- •Non convulsive status epilepticus.
- •Children with known contraindication or allergy to levetireacetam or phenytoin.
研究组 & 干预措施
Levetiracetam
The levetiracetam dose is 20- 40 mg/kg by intravenous infusion over 15 minute, a rate of 2-5 mg/kg/minute diluted in 100 ml with 0.9% sodium chloride as a single dose.
干预措施: Levetiracetam Injection (Drug)
Phenytoin
Phenytoin dose is 20-40 mg/kg/min by intravenous infusion over 30 minute, diluted with 0.9% sodium chloride to a maximum concentration of 10 mg/ml.
干预措施: Phenytoin Injection (Drug)
结局指标
主要结局
cessation of convulsion
时间窗: 30 minutes
seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG
次要结局
- bradycardia(6 hours)
- respiratory depression(6 hours)
- decreased conscious level(6 hours)
- hypotension(6 hours)
研究者
Amira Hamed Darwish
Professor of pediatrics and Principal Investigator
Tanta University