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

NCT ID: NCT06626620

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-09-30

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.

Conditions

Acute Exacerbation of Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV Magnesium Sulfate

Magnesium sulfate, a smooth muscle relaxant, has been shown to have bronchodilatory effects by inhibiting calcium influx into smooth muscle cells.

Group Type: EXPERIMENTAL

Magnesium Sulphate infusion

Intervention Type: DRUG

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

IV Terbutaline

Terbutaline, a beta-2 agonist, is used intravenously to provide systemic bronchodilation when inhaled bronchodilators are not effective.

Group Type: EXPERIMENTAL

Terbutaline Infusion

Intervention Type: DRUG

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

Interventions

Magnesium Sulphate infusion

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

IV MgSO4

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nishtar Medical University

OTHER

Sponsor Role: collaborator

Muhammad Aamir Latif

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Aamir Latif

Research Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Arif Zulqarnain, FCPS

Role: STUDY_DIRECTOR

Department of Pediatrics, Nishtar Hospital, Multan, Pakistan

Muhammad Salman, FCPS

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Nishtar Hospital, Multan

Locations

Nishtar Hospital

Multan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

NISHTARASTHMASTUDY

Identifier Type: -

Identifier Source: org_study_id