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. 2018 Aug 22;2018(8):CD001955. doi: 10.1002/14651858.CD001955.pub4

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
Interventions Treatment (N = 176): single dose 6 mg dose oral dexamethasone
Control (N = 173): single dose 6 mg oral placebo
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