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Completed

NCT Number: NCT06626620

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

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.

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Key information

Conditions

Acute Exacerbation of Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nishtar Hospital

Multan, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulphate infusion

Drug

Received IV magnesium sulfate (50 mg/kg up to a maximum dose of 2 g) administered over 20 minutes

Other names: IV MgSO4

Terbutaline Infusion

Drug

Received IV terbutaline (10 mcg/kg bolus followed by a continuous infusion of 0.4 mcg/kg/min) for up to 4 hours

Primary outcomes

  1. Post-treatment PEFR

    Time frame: 4 hours

    Post-treatment, children response to treatment was measured by noting PEFR

Secondary outcomes

  1. Oxygen Saturation

    Time frame: 4 hours

    Post-treatment, oxygen saturation was measured using Spirometry

  2. Heart Rate

    Time frame: 4-hours

    Post-treatment, heart rate was measured

  3. Respiratory rate

    Time frame: 4 hours

    Post-treatment, heart rate was measured.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Collaborators

  • Nishtar Medical University

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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