The Efficacy of A Single Dose Clonazepam Compared With the Intermittent Diazepam to Prevent Recurrent Febrile Seizures in Queen Sirikit National Institute of Child Health
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Recurrent rate of febrile seizures
研究概览
简要总结
To study the efficacy and safety of single dose clonazepam compared with intermittent oral diazepam for prevention of recurrent febrile seizures in children who had three or more febrile seizures.
详细描述
Febrile seizures are the most common type of seizures disorder of young children. The risk of recurrences are 33 percent overall, half of them had at least one recurrent seizure (the 3rd febrile seizures). After that the recurrent rate is 50-100 percent depend on their risk factors. A few studies found that multiple recurrent febrile seizures might associated with language developmental delayed, poor speed performance quotient, Attention deficit hyperactivity disorders. Moreover, seizures are upsetting both parents and children. During the febrile illness, the intermittent diazepam, continuous phenobarbital and valproate are effective for prevention of the recurrences. Because of the benign nature of a simple febrile seizures, the risks of side effects generally outweigh the benefits. However, there is no clinical guidelines for prevention of recurrent febrile seizures in the children who experienced multiple occurrences. The better prophylactic drug; safe, effective and easy to use, for prevention of recurrent febrile seizures in children with multiple recurrences might be needed. Clonazepam, the long half-life benzodiazepine, is commonly used for treatment of epilepsy may be effective in preventing recurrent febrile seizures. This study, a single-blind, randomized clinical trial, single dose clonazepam at the time of fever present compared with oral diazepam during the fever to prevent the recurrent febrile seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 6-60 months at date of enrollment
- •3 or more episodes of clinically diagnosed febrile seizures
排除标准
- •history of afebrile seizures or any history suggested the epilepsy
- •history of previous brain insults; CNS infection, birth trauma, traumatic brain injury.
- •delayed developmental milestones
- •abnormal neurological examinations
- •currently treatment by continous antiepileptic drug(s)
- •A contraindication to Clonazepam, Diazepam such as drug hypersensitivity, liver disease.
- •Predictable lack of available of follow up.
研究组 & 干预措施
Intermittent oral diazepam
Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr) start at the time of body temperature more than 38 degree Celsius.
干预措施: Diazepam Tablets (Drug)
Single dose Clonazepam
Clonazepam(0.5 mg/tablet) 0.02 mg/kg orally once at the time of fever present. (body temperature more than 38 degree Celsius)
干预措施: Clonazepam 0.5 MG (Drug)
结局指标
主要结局
Recurrent rate of febrile seizures
时间窗: the assessment will be done at 12 months after enrollment
Rate of seizure occurs when the children have febrile illnesses (at the onset of fever until fever gone). The seizures will be reported by their parents/caregivers. (via the seizure record form and the interview.) Statistic analysis: Cumulative incidence (person-year). percent. Comparison between the two group by unpaired t test.
次要结局
- Number of participants with adverse reaction of medications(7 days)
- Associated factors: Sex(at the enrollment.)
- Associated factors: age at first febrile seizure(at the enrollment)
- Associated factors: the lowest temperature that cause seizure(at the enrollment.)
- Number of participants with febrile convulsions in parents or siblings(at the enrollment.)
- Number of participants with type of febrile seizures (simple or complex)(at the enrollment.)
- Number of participants with epilepsy in parents or siblings(at the enrollment.)
- Number of participants with delayed developmental milestones(at the enrollment.)
研究者
Kullasate Sakpichaisakul
Director of Pediatric Neurology
Queen Sirikit National Institute of Child Health