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Comparing the Outcome of Buccal Midazolam and Intramuscular Midazolam in Children Presenting With Seizures.

2026年6月11日 更新者:Muhammad Tayyab Qureshi、Pakistan Air Force (PAF) Hospital Islamabad

Comparison of Buccal Midazolam Versus Inter-muscular Midazolam in Control of Seizures

The goal of this clinical trial(Quasi Experimental) is to compare efficacy of oral midazolam over intra-muscular Midazolam in children suffering from seizures. The main question it aims to answer is:

Does Buccal midazolam has a better efficacy as compared to intramuscular midazolam in children presenting with seizures?

There will be two groups determined by randomisation and then one will be given buccal midazolam and other will will be administered IM Midazolam .The out come will be determined by the determining the cessation of seizures within 5 minutes duration achieved by administration of drug.

研究概览

地位

完全的

干预/治疗

详细说明

  1. Introduction:

    Generalised convulsive seizure is a serious and potentially life threatening medical emergency that requires prompt intervention. Administration of buccal midazolam is an efficient and easier method for control of seizures without the need for intravenous cannulation expertise or intramuscular injections.

  2. Objectives:

    To compare the outcome of buccal midazolam versus intramuscular midazolam in children presenting with seizures.

  3. Study Design:

    It is RCT

  4. Settings:

    Pediatric Medicine Department, PAF hospital, Islamabad

  5. Study Duration:

15th January 2022 to 14th July 2022

6. Materials & Methods: A total of 90 patients of both genders, 6 months to 12 years of age, presenting with seizures were included. Children with cardiac arrest or haemodynamic instability at presentation, head trauma or drowning, metabolic disorders, CKD were excluded.

All the patients were divided into two groups by lottery method.

In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml).

In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml). They were followed till resolution of symptoms. If seizure resolved within 5 minutes, then success was labelled.

研究类型

介入性

注册 (实际的)

90

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Capital
      • Islamabad、Capital、巴基斯坦、44000
        • PAF Hospital Islamabad

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Children of age 6 months to 12 years, both genders, presenting with seizures (as per operational definition)
  2. Children with Seizure disorder, Febrile fits, Meningitis without raised intracranial pressure.

Exclusion Criteria:

  1. Children with cardiac arrest or hemodynamic instability at presentation, head trauma or drowning.
  2. Diagnosed cases of metabolic disorders, CKD.
  3. Diagnosed case of raised ICP.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Buccal Midazolam
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml).
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml). In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml).
有源比较器:Intramuscular Midazolam
In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml)
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml). In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cessation of seizues
大体时间:5 minutes after drug administered

Cessation of seizures within 5 minutes duration achieved by administration of drug will be determined as success. Based on this cut off value for time we obtained dichotomous results i.e, Successful or Not Successful.

  1. Seizures resolving > 5 minutes considered unsuccessful.
  2. Seizures resolving < 5 minutes considered successful.
5 minutes after drug administered

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Prof Dr Asma Shabbir, MBBS,FCPS(Paediatrics),MHPE、Pakistan Air Force Hospital Islamabad

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年1月15日

初级完成 (实际的)

2022年5月14日

研究完成 (实际的)

2022年6月14日

研究注册日期

首次提交

2026年5月31日

首先提交符合 QC 标准的

2026年5月31日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

It's due to confidentiality purpose.Stats will be shared on demand only.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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