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OpenTrials
Completed

NCT Number: NCT06754631

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

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.

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Key information

Conditions

Asthma in Children

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nishtar Hospital, Multan, Punjab Province, Pakistan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Nebulization of Salbutamol

Drug

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).

Intermittent Nebulization of Salbutamol

Drug

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.

Primary outcomes

  1. Discharge

    Time frame: 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 outcomes

  1. Hospital stay

    Time frame: 24 hours

    The length of stay in the hospital was calculated from admission to discharge.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Collaborators

  • Nishtar Medical University

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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