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

NCT06754631 | Completed

• 1 other identifier: CHM-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Discharge

  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.

  4 hours

Secondary Outcomes (1)

• Hospital stay

  24 hours

Study Arms (2)

Continuous Nebulization of Salbutamol

EXPERIMENTAL

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).

Drug: Continuous Nebulization of Salbutamol

Intermittent Nebulization of Salbutamol

EXPERIMENTAL

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.

Drug: Intermittent Nebulization of Salbutamol

Interventions

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).

Continuous Nebulization of Salbutamol

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.

Intermittent Nebulization of Salbutamol

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Nishtar Hospital

Multan, Punjab Province, 66000, Pakistan

Location

The Children's Hospital and The Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

Location

Study Officials

• Arif Zulqarnain, FCPS

  Children's Hospital and institute of Child Health Multan, Punjab, Pakistan

  STUDY DIRECTOR

• Muhammad Salman, FCPS

  Children's Hospital and institute of Child Health Multan, Punjab, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: December 23, 2024
• First Posted: January 1, 2025
• Study Start: April 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)