Comparison of Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze

Not Applicable

Completed

• Conditions: Childhood Asthma With Acute Exacerbation
• Interventions: Device: Metered Dose Inhaler With Spacer Device

• Registration Number: NCT06201156
• Lead Sponsor: Khyber Teaching Hospital

Brief Summary

The goal of this randomized controlled trial is to compare two different devices for the administration of the standard protocol drug. The main question it aims to answer is are metered dose inhalers with spacer device as effective as nebulization with salbutamol in treatment of childhood wheeze

Children will be divided in two groups using block randomization method. Children in group A will be nebulizer group, treatment will consist of 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min.

For patients in group B spacer group, treatment consisted of 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals. For administration of the MDI, the investigator will dispense I puff of salbutamol or placebo into the spacer and held the mask on the child's face while the child breathed 5 to 6 times through the mask. This process will b-e repeated for a total of 3 puffs per treatment. All patients will be treated by the principal investigator, at end of treatment need for admission and pulmonary index will be noted.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-10
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-31
• Study First Posted: 2024-01-11
• Primary Completion: 2024-02-20
• Study Completion: 2024-03-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Patients aged 6 to 24 months

• Patients of both gender
• Patients presenting to emergency department with bilateral wheeze

Exclusion Criteria

Patients with history of chronic lung condition (including congenital anomalies, cystic fibrosis, and bronchopulmonary dysplasia).

• Patients with history of congenital heart disease.
• Patients with history of intubation for longer than 1 week during the neonatal period.
• Patients having symptoms consistent with croup.
• Patients with signs of impending respiratory failure i.e Pulmonary index score of 12.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A / Nebulizer Group	Metered Dose Inhaler With Spacer Device	Group A/ Nebulizer group will receive 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min.
Group B / MDI with Spacer Device Group	Metered Dose Inhaler With Spacer Device	Group B/ MDI with Spacer Group will receive 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals.

Primary Outcome Measures

Name	Time	Method
compare mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers	1 hour	primary outcome is defined as Comparison of mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers with spacers for treatment of wheezing in children aged 6 to 24 months in a pediatric emergency department

Trial Locations

Locations (1)

Khyber Teaching Hospital; 🇵🇰 Peshawar, Pakistan