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临床试验/CTRI/2025/12/099967
CTRI/2025/12/099967尚未招募3 期

Effectiveness and Safety Of Add On- Nebulized MgSO4 with salbutamol and Salbutamol Alone in Bronchial Asthma Management in Children of 6-12 Years. A Randomized controlled Trial.

Aarupadai Veedu medical college and hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年1月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
126
试验地点
1
主要终点
To evaluate the mean duration of hospital stay and change in clinical severity score parameters (respiratory rate ,o2 saturation , wheezing , retraction, general condition)

研究概览

简要总结

This study is a randomized parallel group active controlled trial conducted to evaluate the effectiveness and safety of add on nebulized magnesium sulfate in combination with salbutamol compared to salbutamol alone in the management of acute bronchial asthma in children aged 6 to 12 years. A total of 126 children diagnosed with acute bronchial asthma and requiring hospital admission will be enrolled and randomly allocated into two groups. The intervention group will receive nebulized magnesium sulfate 100 mg in combination with salbutamol 2.5 mg while the control group will receive nebulized salbutamol 2.5 mg with isotonic saline. Nebulization will be administered every 20 minutes for four doses using a jet nebulizer with oxygen. The primary outcome will be improvement in clinical severity score and peak expiratory flow rate. Secondary outcomes include duration of hospital stay and occurrence of adverse events. The study aims to generate evidence on the role of nebulized magnesium sulfate as an add on therapy in pediatric acute bronchial asthma.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children between 6 years and 12 years of age with acute bronchial asthma.

排除标准

  • Children below 6 years of age Cardiac diseases such as congenital heart diseases Preterm birth or history of mechanical ventilation in neonatal period History of pneumonia.

结局指标

主要结局

To evaluate the mean duration of hospital stay and change in clinical severity score parameters (respiratory rate ,o2 saturation , wheezing , retraction, general condition)

时间窗: Assess pre treatment severity before 1st nebulization. | Detect early response after 1st dose(after 6 hours of 1st dose), Evaluate ongoing improvement (on day 2,3,4) and final clinical outcome based on reduction of clinical severity score (on day 5)

次要结局

未报告次要终点

研究者

发起方
Aarupadai Veedu medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ramadoss gandhi karthikeyan

Aarupadai veedu medical college and hospital

研究点 (1)

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