A comparison of intravenous levetiracetam and phenytoin combination versus phenytoin and placebo combination in children with benzodiazepine resistant convulsive epileptics -a double blinded randomised control trail
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To compare the proportion of children with successful clinical termination of seizure activity within 30 min after initiation of drug infusion in either group (Phenytoin and Levitracetam versus Phenytoin and placebo )
研究概览
简要总结
Status Epilepticus (SE) being one of the most common life threatening neurological emergency in children requires a prompt intervention for early control of seizures to prevent short term and long term morbidity. There is increased mortality and morbidity due to not only the cause and duration of SE but also its management.Current antiepileptic drugs for SE are given in succession to achieve seizure control.We want to shorten the delay in seizure control and also increase the proportion of seizure control by combining two antiepileptic drugs acting at two different sites, by administering them simultaneously and rapidly. Research question: Whether Levetiracetam and phenytoin combination is better in seizure control than phenytoin and placebo combination in children with benzodiazepine resistant status epilepticus. study location: Pediatric ER and PICU of Advanced Pediatric Center , PGIMER , Chandigarh In this study it is proposed to give injection phenytoin and levetiracetam concurrently in SE not responding to initial 2 doses of benzodiazepine, in children aged 3months-12yrs. The primary objective: Proportion of seizure control within 30 minutes of starting drug infusion Secondary objective: Recurrence of seizure with in 8 hours , correlating seizure control with drug levels of phenytoin and levetiracetam at end of 1 hour of infusion and adverse effects of the study drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 3month to 12 years presenting with convulsive status epilepticus(CSE) or occurrence of status epilepticus at pediatric Emergency or PICU of advanced pediatric center of PGIMER Eligibility criteria: Minimum two doses of benzodiazepines as first line treatment is to be given.
排除标准
- •4.3.1.Absence, myoclonic, non-convulsive status epilepticus, or infantile spasms Known case of chronic renal disease Previous administration of loading any IV antiepileptic drug within last 12 hours of enrollment.
结局指标
主要结局
To compare the proportion of children with successful clinical termination of seizure activity within 30 min after initiation of drug infusion in either group (Phenytoin and Levitracetam versus Phenytoin and placebo )
时间窗: within 30 minutes of starting the drug infusions
次要结局
- To compare the proportion of children with recurrence of seizure within 8 hours of stopping infusionCorrelation of serum drug levels of levetiracetam and phenytoin with seizure control(To compare the proportion of children with adverse events due to either phenytoin and levetiracetam combination or phenytoin and placebo combination)