Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma

Not Applicable

• Conditions: Asthma
• Interventions: Drug: Magnesium Sulfate

• Registration Number: NCT01584726
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

The purpose of this study is to investigate the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency.

Detailed Description

the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency

follow asthma severity score and length of stay

Study Timeline

• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-25
• Study Start: 2012-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-28
• Primary Completion: 2015-03
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Pediatric asthma patients with moderate to severe exacerbation

Exclusion Criteria

• Known allergy to magnesium sulfate
• History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
• Use of oral steroid medication within 72 hours of presentation
• Radiographic evidence of pneumonia at presentation
• Administration of intravenous magnesium sulfate prior to study enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
magnesium sulfate arm	Magnesium Sulfate	magnesium sulfate with standard therapy

Primary Outcome Measures

Name	Time	Method
Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma significantly reduce the time to clinical readiness for discharge?	36 months

Secondary Outcome Measures

Name	Time	Method
• Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease admission and readmission rate, compared to placebo	36 months	* Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease PICU admission rate, compared to placebo?; * Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma improve change in asthma severity score at 4, 8, 12 hours, compared to placebo?; * Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease return rate to emergency services, compared to placebo?; * Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease rate of infirmray admission in follow up, compared to placebo?

Trial Locations

Locations (2)

Pediatric Emergency Centre; 🇶🇦 Doha, Qatar

Hamad Medical Corporation; 🇶🇦 Doha, Qatar