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

NCT ID: NCT06754631

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Continuous Nebulization of Salbutamol

Intervention Type 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

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.

Group Type EXPERIMENTAL

Intermittent Nebulization of Salbutamol

Intervention Type 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.

Interventions

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Continuous 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).

Intervention Type DRUG

Intermittent 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nishtar Medical University

OTHER

Sponsor Role collaborator

Muhammad Aamir Latif

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Aamir Latif

Research Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Arif Zulqarnain, FCPS

Role: STUDY_DIRECTOR

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

Muhammad Salman, FCPS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Nishtar Hospital

Multan, Punjab Province, Pakistan

Site Status

The Children's Hospital and The Institute of Child Health

Multan, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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CHM-1

Identifier Type: -

Identifier Source: org_study_id

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