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临床试验/CTRI/2025/08/092538
CTRI/2025/08/092538招募中2/3 期

Comparison between nebulized magnesium sulphate with salbutamol and nebulized salbutamol alone as a first line management for acute exacerbation of asthma in pediatrics population- A Randomised control trial

INDIRA GANDHI MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月17日最近更新:

试验速览

阶段
2/3 期
状态
招募中
入组人数
80
试验地点
1
主要终点
The primary outcome is the difference in improvement of PEFR between the 2 groups

研究概览

简要总结

In this study we will enroll all the patients of asthma presenting to emergency with acute exacerbation, and along with nebulised salbutamol, we will give nebulized magnesium sulfate during the initial nebulization treatment to the case group. We will subsequently record the improvement in PEFR and PRAM score in case and control group at different time intervals. If proven effective, this approach would improve emergency care protocols and provide better management of asthma exacerbation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
5.00 Year(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • Children between the ages of 5-17 years of age diagnosed as acute exacerbation of asthma.
  • And have an initial pediatric respiratory assessment measure (PRAM) more than
  • Or is a known case of childhood asthma or past history of similar episodes relieved with bronchodilator therapy or already on Controller therapy or family history of asthma/ atopy/ nebulisations or personal history of atopic dermatitis/ food allergy/ allergic rhinitis.

排除标准

  • 未提供

结局指标

主要结局

The primary outcome is the difference in improvement of PEFR between the 2 groups

时间窗: The primary outcome is the difference in PEFR at 0, 20, 60 min and 24 hrs

次要结局

  • Improvement in PRAM score at 0 min, 20 min, 60 min, 24 hrs(Requirement of iv magnesium sulphate.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Bhanupriya Sharma

IGMC shimla

研究点 (1)

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