Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma

Phase 3

Completed

• Conditions: Acute Exacerbation of Asthma
• Interventions: Drug: Magnesium Sulphate infusion; Drug: Terbutaline Infusion

• Registration Number: NCT06626620
• Lead Sponsor: Muhammad Aamir Latif

Brief Summary

This study aimed to fill this gap by comparing the effectiveness of intravenous magnesium sulfate versus terbutaline in children with acute asthma exacerbations, providing evidence-based guidance for clinicians in emergency settings.

Detailed Description

Despite the established roles of both magnesium sulfate and terbutaline in the management of severe asthma exacerbations, there is limited comparative data on their efficacy and safety in the pediatric population. Understanding the relative benefits and risks of these therapies is crucial for optimizing treatment strategies and improving patient outcomes.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Known cases of asthma
• Minimum duration of asthma as 6 months
• Presenting with acute exacerbation of asthma
• Requiring emergency treatment.

Exclusion Criteria

• Children having chronic respiratory diseases (cystic fibrosis, bronchopuonary dysplasia)
• Children with cardiac diseases
• Children who were hospitalized in the past 2-weeks due to any reasons
• Children using oral or intravenous corticosteroids or other systemic medications
• Children who were unable to undergo PEFR measurements due to any reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Magnesium Sulfate	Magnesium Sulphate infusion	Magnesium sulfate, a smooth muscle relaxant, has been shown to have bronchodilatory effects by inhibiting calcium influx into smooth muscle cells.
IV Terbutaline	Terbutaline Infusion	Terbutaline, a beta-2 agonist, is used intravenously to provide systemic bronchodilation when inhaled bronchodilators are not effective.

Primary Outcome Measures

Name	Time	Method
Post-treatment PEFR	4 hours	Post-treatment, children response to treatment was measured by noting PEFR

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation	4 hours	Post-treatment, oxygen saturation was measured using Spirometry
Heart Rate	4-hours	Post-treatment, heart rate was measured
Respiratory rate	4 hours	Post-treatment, heart rate was measured.

Trial Locations

Locations (1)

Nishtar Hospital; 🇵🇰 Multan, Punjab, Pakistan