A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
研究概览
简要总结
The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.
详细描述
The ideal first line anticonvulsant agent would be one that can be safely and easily given at a primary health care facility. It should be quick acting, have minimal cardiorespiratory side effects and have a relatively prolonged effect and be cheap. No combination of drug or delivery system fully satisfies these criteria. There are no large published studies evaluating intranasal lorazepam in paediatric status epilepticus. Given its favourable pharmacokinetics and potential practical advantages, we wished to assess the efficacy and safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our existing first line anticonvulsant agent in the treatment of acute seizures in children.
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
- None
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
- •Children aged between 2 months and 12 years
- •Presenting with generalised convulsions
排除标准
- •Any child who had received an anticonvulsant agent within 1 hour of presentation
- •Seizure stopped with rapid cooling or treatment of hypoglycaemia
- •Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy
结局指标
主要结局
whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
次要结局
- time from drug administration to cessation of convulsion
- frequency of episodes requiring 2 or more anticonvulsant agents
- continuous blood pressure and oxygen saturation for 30 minutes post drug administration
- seizure recurrence within 24 hours of cessation of presenting convulsion
- survival/death