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

October 2, 2024 updated by: Muhammad Aamir Latif
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan
        • Nishtar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV Magnesium Sulfate
Magnesium sulfate, a smooth muscle relaxant, has been shown to have bronchodilatory effects by inhibiting calcium influx into smooth muscle cells.
Drug: Magnesium Sulphate infusion
Received IV magnesium sulfate (50 mg/kg up to a maximum dose of 2 g) administered over 20 minutes
Other Names:
  • IV MgSO4
Experimental: IV Terbutaline
Terbutaline, a beta-2 agonist, is used intravenously to provide systemic bronchodilation when inhaled bronchodilators are not effective.
Drug: Terbutaline Infusion
Received IV terbutaline (10 mcg/kg bolus followed by a continuous infusion of 0.4 mcg/kg/min) for up to 4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-treatment PEFR
Time Frame: 4 hours
Post-treatment, children response to treatment was measured by noting PEFR
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Saturation
Time Frame: 4 hours
Post-treatment, oxygen saturation was measured using Spirometry
4 hours
Heart Rate
Time Frame: 4-hours
Post-treatment, heart rate was measured
4-hours
Respiratory rate
Time Frame: 4 hours
Post-treatment, heart rate was measured.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Aamir Latif

Collaborators

Nishtar Medical University

Investigators

  • Study Director: Arif Zulqarnain, FCPS, Department of Pediatrics, Nishtar Hospital, Multan, Pakistan
  • Principal Investigator: Muhammad Salman, FCPS, Department of Pediatrics, Nishtar Hospital, Multan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NISHTARASTHMASTUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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