| Methods |
Design: randomised controlled trial
Method of randomisation: not stated
Means of allocation concealment: not stated
Withdrawals/drop‐outs: 1 patient in the placebo/placebo group was excluded from the study at 60 min because of worsening clinical status and was admitted
Blinding: double‐blind, placebo controlled |
| Participants |
Eligible: unclear
Randomised: (placebo/inhaled/oral corticosteroids): 15/17/17
Completed: placebo 14, inhaled 17, oral 17
Sex (M/F): placebo 9/6, inhaled 8/9, oral 8/9
Age (mean (SD)) (months): placebo 49.6 (15.6), inhaled 51.1 (18.7), oral 47.3 (16.3)
Asthma diagnosis: ≥ 3 previous episodes, current episode lasting ≥ 6 h
Inclusion criteria: moderate acute asthma defined as audible wheeze, use of accessory muscles, increased RR and an inability either to walk or to speak more than 3 to 5 words per breath
Exclusion criteria: chronic or acute cardiopulmonary disease, use of systemic corticosteroids within the past 14 days, use of ICS within the past 72 h, severe exacerbations, other previous medical conditions |
| Interventions |
Setting: patients with acute asthma who sought treatment at the paediatric walk‐in clinic at 1 hospital in Brazil
Intervention: this trial had 3 treatment groups. Group 1 received inhaled placebo and oral placebo. Group 2 received inhaled placebo and oral prednisone 1 mg/kg. Group 3 received nebulised budesonide 2 mg and oral placebo
All patients received nebulised salbutamol 0.15 mg/kg. This was repeated if the patients' severity scores or oxygen saturations worsened. After 4 h' observation, patients were discharged with a prescription for inhaled bronchodilators |
| Outcomes |
Primary outcome were clinical severity scores and oxygen saturations. The clinical severity score was calculated based on: RR, wheezing, retraction, dyspnoea and oxygen saturation |
| Notes |
This trial was included in July 2005 in both the primary and secondary analyses. 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 |
1 patient in the placebo/placebo group was excluded from the study at 60 min because of worsening clinical status and was admitted |
| Selective reporting (reporting bias) |
Unclear risk |
No apparent indication of reporting bias |
