Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Post-treatment PEFR
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IV Magnesium Sulfate
Magnesium sulfate, a smooth muscle relaxant, has been shown to have bronchodilatory effects by inhibiting calcium influx into smooth muscle cells.
Intervention: Magnesium Sulphate infusion (Drug)
IV Terbutaline
Terbutaline, a beta-2 agonist, is used intravenously to provide systemic bronchodilation when inhaled bronchodilators are not effective.
Intervention: Terbutaline Infusion (Drug)
Outcomes
Primary Outcomes
Post-treatment PEFR
Time Frame: 4 hours
Post-treatment, children response to treatment was measured by noting PEFR
Secondary Outcomes
- Oxygen Saturation(4 hours)
- Heart Rate(4-hours)
- Respiratory rate(4 hours)
Investigators
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research