Vad Pedersen 1998.
| Methods | Randomised controlled trial | |
| Participants |
Study period: October 1989 to September 1990 Setting: paediatric department of Esbjerg Centralsygehus (Central Hospital), Denmark Inclusion criteria: children hospitalised with croup based on a modified Westley croup score ≥ 3 (including chest wall retractions, barking cough, respiratory frequency, and stridor) Exclusion criteria: required immediate intensive care; clinical suspicion of epiglottitis; cyanosis; croup recurrence; had received local or systemic steroid treatment; being treated with carbamazepine, phenobarbital, or rifampicin Baseline demographics (N = 59, 2 excluded): proportion males: 63% mean age in months: treatment 1: 23.8; treatment 2: 24.1 mean (SD) croup score: treatment 1: 3.67 (1.02); treatment 2: 4.17 (0.99) |
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| Interventions | Treatment 1 (N = 27): 2, 1000 μg doses of inhaled budesonide at 30‐minute intervals Treatment 2 (N = 29): single 0.6 mg/kg (0.15 mL/kg) dose of intramuscular dexamethasone |
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| Outcomes | Change in croup score from baseline to 6 and 12 hours; return visits to the hospital; use of supplemental glucocorticoids | |
| Notes | Written in Danish; funding source: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: block randomisation with varying block size |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information provided to judge. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: unblinded. Subjective outcomes |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: unblinded. Subjective outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 3% (N = 2) who were randomised were excluded due to protocol deviations. |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol identified. All prespecified outcomes from methods appear in results. |
| Other bias | High risk | Comment: baseline imbalance in croup score |
| Overall risk of bias All outcomes | High risk | Comment: at least 1 domain judged as high risk. |