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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06754631
Enrollment
120
Registered
2025-01-01
Start date
2024-04-01
Completion date
2024-09-30
Last updated
2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children

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.

Interventions

DRUGContinuous Nebulization of Salbutamol

Children 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).

DRUGIntermittent Nebulization of Salbutamol

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 Children received at least 2-3 nebulizations and no more than 7.5 mg/dose every 30 minutes for 4 hours.

Sponsors

Nishtar Medical University
CollaboratorOTHER
Muhammad Aamir Latif
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Discharge4 hoursWhen 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

MeasureTime frameDescription
Hospital stay24 hoursThe length of stay in the hospital was calculated from admission to discharge.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026