Efficacy and Safety of Continuous Versus Intermittent Nebulization of Salbutamol in Acute Severe Asthma in Children Under 12 Years of Age

Not Applicable

Completed

• Conditions: Asthma in Children
• Interventions: Drug: Continuous Nebulization of Salbutamol; Drug: Intermittent Nebulization of Salbutamol

• Registration Number: NCT06754631
• Lead Sponsor: Muhammad Aamir Latif

Brief Summary

Asthma affects around 260 million people globally, causing around 0.5 million deaths annually. Pediatric asthma remains a major global public health challenge, significantly affecting the quality of life for many children. Therefore, this study was planned to compare the effects of continuous versus intermittent nebulization of salbutamol in the treatment of acute severe asthma (ASA) in children visiting the emergency department of a tertiary childcare hospital in South Punjab, Pakistan.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Children of either gender
• Aged 2 to 12 years
• Diagnosed with moderate exacerbation of acute asthma according to British Guidelines on the Management of Asthma, with a clinical asthma score of 8 or more

Exclusion Criteria

• Children who were prescribed with other first-line therapy, such as adrenaline or 3% NaCl nebulization
• Presented at imminent risk of respiratory arrest
• Congenital heart disease
• Chronic respiratory disease
• Neurological disorders
• Children referred from any other hospital with no data available on emergency treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Nebulization of Salbutamol	Continuous Nebulization of Salbutamol	The patients received continuous nebulization of salbutamol at a concentration of 0.3 mg/kg/hour for 4 hours, with a minimum of 5 mg/hour and a maximum of 15 mg/hour administered via high-output extended aerosol respiratory therapy (HEART).
Intermittent Nebulization of Salbutamol	Intermittent Nebulization of Salbutamol	The patients were treated with intermittent nebulization of salbutamol at a dose of 0.15 mg/kg/dose, administered through a face mask with an oxygen flow rate of 6-8 L per minute. They received at least 2-3 nebulizations and no more than 7.5 mg/dose every 30 minutes for 4 hours.

Primary Outcome Measures

Name	Time	Method
Discharge	4 hours	When patients met the clinical criteria for discharge, which were an asthma score of 5 or less and a saturation level of over 94% on room air.

Secondary Outcome Measures

Name	Time	Method
Hospital stay	24 hours	The length of stay in the hospital was calculated from admission to discharge.

Trial Locations

Locations (2)

Nishtar Hospital; 🇵🇰 Multan, Punjab, Pakistan

The Children's Hospital and The Institute of Child Health; 🇵🇰 Multan, Punjab, Pakistan