Clinical trial NCT06201156: Comparison of Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
Official title: Comparison of Pulmonary Index Score After Treatment With Salbutamol Through Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Asthma With Acute Exacerbation
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: compare mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
Study officials:
affiliation: Khyber Teaching Hospital
name: Arooj Khan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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