跳至主要内容
临床试验/NCT04885075
NCT04885075Unknown4 期

A Randomized Controlled Trial Comparing the Efficacy of Intranasal Midazolam and Conventional Treatment With Intravenous Diazepam for Control of Seizures in Children

Shaheed Zulfiqar Ali Bhutto Medical University0 个研究点目标入组 60 人开始时间: 2021年5月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
主要终点
Time taken for seizures to be controlled

研究概览

简要总结

After approval , study will be conducted at the Children Hospital PIMS, Islamabad. Children 1-12 years presenting/admitted with seizures will be enrolled in the study after taking informed consent from the parents. Children's name, age, sex will be recorded by the on duty doctor. Patients will be randomly allocated to two equal groups. Group A (GA) will receive single dose of intravenous diazepam (0.2mg/kg/dose)after passing cannula, while Group B (GB) will receive single dose of intranasal midazolam (0.2mg/kg/dose).Response to treatment will be assessed by recording the time required for termination of seizures in both gruops.the time required for gaining intravenous accessin Group A will be recorded as well. Data will be collected through a structured performa.

详细描述

Benzodiazepines are the first line of drugs for cessation of acute seizures.benzodizepines can be given intravenous,orally,per rectal and intranasal.Conventional treatment of acute seizures is intravenous diazepam in most hospital settings which requires an IV access,which is not possible for parents to give at home.The main problem in an actively seizuring child is to reach the hospital and maintaining an intravenous line.Midazolam is a water soluble benzodiazepine which is widely used as an anxiolytic and anticonvulsant ,can be given through intravenously,intramuscularly, oral,buccal and nasal mucosa as well.it becomes lipid soluble at physiologic PH levels and reaches the CNS with a rapid onset and shorter duration of action.It is administered into nostril in a way that it comes into direct contact with nasal mucosa.It is given in a dose of 0.2mg\kg and within a few minutes its level in serum are comparable to the injectables levels.It is a safe,cheap,easy to use and effective alternative to diazepam for use at home as well as in hospital settings.

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
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 1-10 years both male and female visiting/admitted in Children Hospital PIMS with acute episode of seizure (febrile or afebrile)

排除标准

  • Children requiring emergency resuscitation
  • Children with uncontrolled epilepsy

研究组 & 干预措施

Intravenous Diazepam

Other

Intravenous diazepam (0.2mg/kg/dose) single dose stat

干预措施: IV diazepam (Drug)

Intranasal Midazolam

Other

Intranasal midazolam (0.2mg/kg/dose) single dose stat

干预措施: I/N Midazolam (Drug)

结局指标

主要结局

Time taken for seizures to be controlled

时间窗: From administration of drug to the cessation of seizures up to 10 minutes

Intranasal midazolam will take less time for cessation of seizure than intravenous diazepam

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Nighat Haider

assistant professor of paediatrics

Shaheed Zulfiqar Ali Bhutto Medical University

相似试验