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临床试验/NCT04497766
NCT04497766已完成4 期

Comparasion of Efficacy of Nebulized Magnesium Sulphate With Intravenous Magnesium Sulphate in Children With Acute Asthma

Saima Khatoon1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Saima Khatoon
入组人数
148
试验地点
1
主要终点
Efficacy of nebulized magnesium sulphate with intravenous magnesium sulphate in children with acute asthma will be assessed by a drop in PAS score, as assessed at 6 hours of intervention.

研究概览

简要总结

The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in children presenting with acute asthma.Study perfoma consists of demographic variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2 at room air(requirement of oxygen),auscultatory findings in chest,dysnea and retractions.

详细描述

After getting informed consent from guardian,148 patients of acute moderate ro severe asthma with pediatric asthma score 8-15 will be randomly classified into 2 groups and one group will receive nebulization with magnesium sulphate and other will receive intravenous magnesium sulphate and effectiveness will be compared by 4 point reduction in PAS from baseline in either groups after 6 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients with age 2 to 12 years with acute moderate to severe exacerbation of asthma as per operational definition children who are unrespoinsive to standard treatment of asthma at 60 minutes

排除标准

  • those with history of chronic lung disease and abnormal renal function contraindication for MgSO4 due to hepatic or renal disease allergy to MgSo4 children who has other comorbid illness

研究组 & 干预措施

Nebulized magnesium sulphate

Experimental

100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer

干预措施: Nebulized Magnesium sulfate (Drug)

Intravenous magnesium sulphate

Experimental

Magnesium sulphate according to weight will be given intravenously.

干预措施: Intravenous magnesium sulphate (Drug)

结局指标

主要结局

Efficacy of nebulized magnesium sulphate with intravenous magnesium sulphate in children with acute asthma will be assessed by a drop in PAS score, as assessed at 6 hours of intervention.

时间窗: 6 hours

The intervention will be considered effective if there is a drop of at least 4 points in PAS score at hour-6 of intervention.

次要结局

  • duration of hospital stay(120 hours/5 days)
  • duration of ICU stay(72 hours/3 days)

研究者

发起方
Saima Khatoon
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Saima Khatoon

Post Graduate Resident in Pediatrics (MD Paeds)

King Edward Medical University

研究点 (1)

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