A Randomized Controlled Trial Comparing the Prevention of Febrile Seizures in Children with Intermittent Oral Levetiracetam for Two weeks Versus Clobazam
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of Levetiracetam Vs Clobazam in preventing the recurrence of febrile seizure
研究概览
简要总结
Febrile seizures are one of the most coomon emergencies seen in paediatric age group. Febrile seizures can sometimes be extremely frightening moments for parents, even if they are generally harmless, making it important to address parental anxiety in the most sensitive manner.FS are the most common type of convulsions in children. Their prevalence is approximately 5-10% in Indian children.
According to current treatment guidelines we give clobazam to children with febrile seizures to prevent its recurrence. But still we encounter many recurrences. This study will compare the use of Levetericetam( a safer drug) against clobazam in reducing the recurrence of febrile seizure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 60.00 Month(s)（—）
- 性别
- All
入选标准
- •All the children coming in paediatric OPD and emergency who are newly diagnosed with febrile seizures.
排除标准
- •1.Intracranial infections and past episodes of seizure without fever
- •Brain injury/intracranial bleed
- •Currently taking medications to treat epilepsy
- •Children whose parents will not consent for the study.
结局指标
主要结局
To compare the effectiveness of Levetiracetam Vs Clobazam in preventing the recurrence of febrile seizure
时间窗: The Outcome will be assessed at the end of 6months after start of enrollment.
次要结局
- To compare the adverse effects of using Levetiracetam Vs Clobazam among such patients(The Outcome will be assessed at the end of 6months after start of enrollment.)
研究者
Dr Pancham Kumar
Indira Gandhi Medical College and Hospital, Shimla