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

Muhammad Aamir Latif

Status: Completed

Conditions: Asthma in Children

Treatments: Drug: Continuous Nebulization of Salbutamol; Drug: Intermittent Nebulization of Salbutamol

Study type: Interventional

Funder types: Other

Identifiers

NCT06754631

CHM-1

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Continuous Nebulization of Salbutamol

Experimental group

Description:

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).

Treatment:

Drug: Continuous Nebulization of Salbutamol

Intermittent Nebulization of Salbutamol

Experimental group

Description:

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.

Treatment:

Drug: Intermittent Nebulization of Salbutamol