Childhood Asthma With Acute Exacerbation
Conditions
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.
Interventions
DEVICEMetered Dose Inhaler With Spacer Device
Bronchodilator Therapy
Sponsors
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Pakistan
Outcome results
None listed