| Methods |
Design: randomised controlled trial
Method of randomisation: computer generated, blocks of 10
Means of allocation concealment: allocation list kept by pharmacy, who provided study drugs according to the list
Blinding: double‐blind, double‐dummy
Withdrawal/drop‐outs: 17 patients were excluded after randomisation: pneumonia (7), missing scheduled albuterol treatment (3), vomiting study medication (5), parental withdrawal (1) or equipment failure (1) |
| Participants |
Eligible: unclear; convenience sample
Randomised: 62/66
Completed: 56/55
Age (mean (SD)) (months): dexamethasone 64 (39), prednisone 55 (36). Range: 1 to 17
Sex (M/F): dexamethasone 57%/43%, prednisone 62%/38%
Asthma diagnosis: 1 prior episode wheezing, doctor's diagnosis
Inclusion criteria: moderate exacerbation, defined by PIS > 8
Major exclusions: severe exacerbation, defined by PIS > 13 or oxygen saturation < 88%, inhaled or systemic corticosteroids use in the preceding 72 h, vomiting oral study drug x 2, requiring more frequent albuterol than every 30 min or deteriorating status or missing a scheduled albuterol dose by > 10 min, previous enrolment, pneumonia, bronchiolitis or croup
Baseline PIS (median): dexamethasone 10, prednisone 11 |
| Interventions |
Setting: ED at a Children's Hospital in US
Intervention 1: nebulised dexamethasone 1.5 mg/kg x 1
Intervention 2: oral prednisone 2 mg/kg x 1
Both groups received nebulised albuterol 15 mg/kg every 30 min x 3 doses then every 40 min as needed to a maximum of 6 doses, and supplemental oxygen to keep O2 saturation > 92%. On discharge all patients were given a prescription for prednisone 2 mg/kg in 2 divided doses for 5 days, and oral or inhaled albuterol 3 times per day for 7 days. Co‐interventions such as extra doses of beta2‐agonists, theophylline or ipratropium bromide were not permitted |
| Outcomes |
Hospital admissions, change in PIS, time to discharge, vomiting and relapse to additional care after discharge
PIS calculated from scoring RR, wheezing, inspiratory/expiratory ratio, accessory muscle use and oxygen saturation |
| Notes |
This trial was only included in the secondary analysis comparing ICS versus systemic corticosteroids. The author was contacted and provided additional information about the study design; however, the data were not available for further analysis |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random sequence |
| Allocation concealment (selection bias) |
Low risk |
Allocation list kept by pharmacy, who provided study drugs according to the list |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Trial reported as double‐blind, double‐dummy |
| 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 |
17 patients were excluded after randomisation: pneumonia (7), missing scheduled albuterol treatment (3), vomiting study medication (5), parental withdrawal (1) or equipment failure (1) |
| Selective reporting (reporting bias) |
Unclear risk |
No apparent indication of reporting bias |
