| Methods |
Design: randomised, double‐blind, placebo‐controlled study
Method of randomisation: not described
Concealment: identical drug packages, but concealment not described |
| Participants |
Eligible: unclear; convenience sample
Randomised: 60/60
Completed: 60/60
Age (mean (SD)) (years): budesonide 7.8 (2.5), placebo 8.1 (2.9)
Sex (M/F): budesonide 19/11, placebo 20/10
Asthma diagnosis: at least 1 prior attack of asthma within the past 6 months
Major exclusions: severe asthma; patients who had received corticosteroids in the preceding 72 h; and those with pneumonia, pertussis, measles, suspected foreign body, or any other chronic disease
Baseline PEF mean (SD) (%): budesonide group 55 (26), placebo group 53 (20) |
| Interventions |
Setting: ED at a Children's Hospital in India
Intervention 1: 400 μg budesonide x 3 doses through MDI and spacer
Intervention 2: placebo through MDI and spacer
Both groups received nebulised salbutamol 0.15 mg/kg every 30 min x 3 doses then every 30 min as needed, and supplemental oxygen. If there was an inadequate response, co‐interventions such as extra doses of beta2‐agonists, theophylline or corticosteroids were given while blinding was maintained |
| Outcomes |
Change in RR, oxygen saturation, % predicted PEF (in those who could perform it), respiratory distress score, and respiratory distress grade (mild, moderate, severe) |
| Notes |
New reference in 2003. The author was not contacted |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method of random sequence generation not reported |
| Allocation concealment (selection bias) |
Unclear risk |
Method of allocation concealment not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Trial reported as double blind |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Blinding of study personnel responsible for outcome assessment indicates the risk of detection bias would be low |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No indication of patients being withdrawn from the trial but baseline PEF was available for only 28 in the intervention group and 28 patients in the control group |
| Selective reporting (reporting bias) |
Unclear risk |
No apparent indication of reporting bias |
