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Clinical Trials/NCT04497766
NCT04497766
Completed
Phase 4

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

Saima Khatoon1 site in 1 country148 target enrollmentOctober 1, 2019

Overview

Phase
Phase 4
Intervention
Nebulized Magnesium sulfate
Conditions
Asthma in Children
Sponsor
Saima Khatoon
Enrollment
148
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Saima Khatoon

Post Graduate Resident in Pediatrics (MD Paeds)

King Edward Medical University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Nebulized magnesium sulphate

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

Intervention: Nebulized Magnesium sulfate

Intravenous magnesium sulphate

Magnesium sulphate according to weight will be given intravenously.

Intervention: Intravenous magnesium sulphate

Outcomes

Primary Outcomes

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.

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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