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

Phase 4

Completed

• Conditions: Asthma in Children
• Interventions: Drug: Nebulized Magnesium sulfate; Drug: Intravenous magnesium sulphate

• Registration Number: NCT04497766
• Lead Sponsor: Saima Khatoon

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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-04
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Nebulized magnesium sulphate	Nebulized Magnesium sulfate	100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer
Intravenous magnesium sulphate	Intravenous magnesium sulphate	Magnesium sulphate according to weight will be given intravenously.

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
duration of hospital stay	120 hours/5 days	this will be measured in hours
duration of ICU stay	72 hours/3 days	this will be measured in hours

Trial Locations

Locations (1)

King edward medical university/mayo hospital lahore; 🇵🇰 Lahore, Punjab, Pakistan