Von Mühlendahl 1982.
Methods | Randomised double‐blind controlled trial | |
Participants |
Study period: January 1979 to April 1980 Setting: 3 paediatric clinics in West Berlin, Germany Inclusion criteria: children admitted to hospital with a diagnosis of pseudo‐croup to 1 of 3 paediatric clinics in West Berlin Exclusion criteria: children who were already somnolent or cyanotic at admission (stage III or IV or pseudo‐croup) Baseline demographics (N = 406; 349 included in the evaluation): proportion males: not reported age distribution: treatment: 15 were < 1 year; 50 were 1 to 1 11/12 years; 96 were 2 to 5 11/12 years; 15 were 6 to 10 11/12 years control: 11 were < 1 year; 44 were 1 to 1 11/12 years; 107 were 2 to 5 11/12 years; 11 were 6 to 10 11/12 years croup score: treatment: 77 had a score of 1 to 3; 99 had a score ≥ 4 control: 67 had a score of 1 to 3; 106 had a score ≥ 4 |
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Interventions | Treatment (N = 176): single dose 6 mg dose oral dexamethasone Control (N = 173): single dose 6 mg oral placebo |
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Outcomes | Change in croup score from baseline to 6 and 12 hours | |
Notes | Funding source: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: insufficient information provided to judge. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information provided to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: described as double‐blind. Unclear who was blinded. Subjective outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: described as double‐blind. Unclear who was blinded. Subjective outcomes |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: of 406 children, 57 (14%) failed to complete the study. 24 (7%) were eliminated due to protocol violation; 19 (5%) received further doses of steroids; and 4 (1%) developed measles. Unclear what group the lost children were in. Did not use intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol identified. All prespecified outcomes from methods appear in results. |
Other bias | Low risk | Comment: no other sources of bias identified. |
Overall risk of bias All outcomes | Unclear risk | Comment: at least 1 domain judged as unclear risk, and no domains judged as high risk. |
CI: confidence interval ED: emergency department SD: standard deviation SE: standard error