Asthma Exacerbation, Children
Conditions
Keywords
Asthma, Salbutamol, Ipratropium Bromide, Pulmonary Asthma Score
Brief summary
The goal of this clinical trial was to determine if adding ipratropium bromide to salbutamol improves asthma treatment in children. The main question this study aimed to answer was: Does combining ipratropium with salbutamol improve asthma symptoms more effectively than salbutamol alone? Researchers compared salbutamol alone to a combination of salbutamol and ipratropium in children with acute asthma. Participants: (i) Received either salbutamol alone or salbutamol with ipratropium via nebulization for 4 hours (ii) Had their asthma symptoms assessed before and after treatment (iii) Were discharged with continued treatment and counseling if stable This study was conducted in the Department of Pediatric Medicine, Children's Hospital Multan, over six months. A total of 60 children with acute asthma were included.
Detailed description
Children presenting with asthma exacerbation were assessed for eligibility. Eligible participants had their baseline characteristics recorded including age, gender, history of parental asthma, duration of asthma diagnosis, use of asthma controllers (inhaled corticosteroids, Long Acting Beta Agonist (LABA), Montelukast) & baseline pulmonary asthma score. Through lottery method using sequentially numbered sealed opaque envelopes children were assigned to group A and group B treatments. At the end of 4-hours of therapy, pulmonary asthma score was re-assessed by pediatrician not aware of treatment assigned. Once stabilized, the children were discharged on regular nebulization therapy with controller medication after proper counseling.
Interventions
Children were given 0.5% salbutamol aerosol solution (0.15 mg/kg weight, up to a maximum of 5 mg) in 5mL of normal saline solution for 7 min every 20 min for 2 h, and then every 30 min for two more hours. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask.
In addition to Salbutamol nebulization, children received ipratropium bromide nebulization. Ipratropium bromide solution (250 mcg in children \<20 kg weight or 500 mcg in children \>=20 kg) every 20 min for the first 2 hours then every 30 min for 2 hours more will be given in between the salbutamol nebulization. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask.
Sponsors
Children's Hospital and Institute of Child Health, Multan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Children with acute asthma exacerbation (presenting with wheeze, labored breathing with ronchi audible on auscultation) * Within 12 hours of symptom onset
Exclusion criteria
* Children with known pulmonary and/or cardiac congenital malformations * Bronchopulmonary dysplasia * Cystic fibrosis * Post infectious bronchiolitis obliterans * Altered mental status on presentation with imminent respiratory failure (pulmonary asthma score ≥ 10, cases needing PICU care)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Asthma Score (PAS) | On presentation and four hours after treatment. | Asthma severity was assessed using Pulmonary Asthma score. It uses respiratory rate, wheezing, inspiration to expiration ratio (I:E) and use of accessory muscles graded 0 - 3 with total score of 12. |
Countries
Pakistan
Outcome results
None listed