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

NCT06626620 | Completed Phase 3

• 1 other identifier: NISHTARASTHMASTUDY
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Exacerbation of Asthma

Keywords

Asthma; intravenous; magnesium sulfate; terbutaline

Outcome Measures

Primary Outcomes (1)

• Post-treatment PEFR

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

  4 hours

Secondary Outcomes (3)

• Oxygen Saturation

  4 hours

• Heart Rate

  4-hours

• Respiratory rate

  4 hours

Study Arms (2)

IV Magnesium Sulfate

EXPERIMENTAL

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

IV Terbutaline

EXPERIMENTAL

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

Drug: Terbutaline Infusion

Interventions

Magnesium Sulphate infusion DRUG

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

Also known as: IV MgSO4

IV Magnesium Sulfate

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

IV Terbutaline

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead
• Nishtar Medical University: collaborator

Study Sites (1)

Nishtar Hospital

Multan, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Arif Zulqarnain, FCPS

  Department of Pediatrics, Nishtar Hospital, Multan, Pakistan

  STUDY DIRECTOR

• Muhammad Salman, FCPS

  Department of Pediatrics, Nishtar Hospital, Multan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: January 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)