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临床试验/CTRI/2024/09/073174
CTRI/2024/09/073174尚未招募4 期

Comparison between intranasal midazolam and intravenous midazolam in children with seizures (randomised controlled study)

TN MOHAMMED NADHEEM1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
164
试验地点
1
主要终点
Intranasal midazolam group –repeat one more dose of Intranasal midazolam-if at all

研究概览

简要总结

This prospective randomized controlled trial will be conducted in the casualty,picu, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL after the approval of research committee and institutional ethics committee. Children in the age group of 6 months to 13 years presenting with acute seizures based on risk of recurrence, child was admitted in emergency department or pediatrics department ICU in SMVMCH fulfilling inclusion criteria will be considered for the study. Randomization technique will be used to select the intervention Group A(Intranasal midazolam ) and Group B (intravenous midazolam) to be given to the study participants. An online resource (www.sealedenvelope.com) will be used to create this block randomized list. The random list order of interventions will be printed in cards and kept in sealed envelopes in the order as in the list. Each envelope will be opened just before the procedure and the intervention which is written on the card will be administered. The list generated is attached as an annexure. The block randomization will be done in two study groups. Group A (Intranasal midazolam ) and Group B (Intravenous midazolam).The route of drugs given by two methods will re assessed at every 3-5 minutes . If Children not meeting the inclusion criteria will be excluded from the study

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
6.00 Month(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Children with acute seizure, febrile seizure, unprovoked seizure, provoked seizure,Children who are a known case of seizure disorder.

排除标准

  • Children with prolonged seizure(status epilepticus), Children‟s with renal diseases, Children with hypoglycemic seizures, hypocalcemic seizure, URI.

结局指标

主要结局

Intranasal midazolam group –repeat one more dose of Intranasal midazolam-if at all

时间窗: 2 MINS

seizure does not abort the Principal Investigator should shift to Intravenous midazolam

时间窗: 2 MINS

routes.

时间窗: 2 MINS

次要结局

  • Intravenous midazolam - if seizure does not abort in first dose of Intravenous midazolam –(repeat one more dose of Intravenous midazolam . If at all seizure does not abort in Intranasal)

研究者

发起方
TN MOHAMMED NADHEEM
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr TN MOHAMMED NADHEEM

Sri manakula vinayagar medical college and hospita

研究点 (1)

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