Eden 1964.
Study characteristics | ||
Methods | Randomised, double‐blind controlled trial | |
Participants |
Study period: not reported Setting: hospital in the USA Inclusion criteria: children hospitalised for treatment of acute croup, including all children with acute respiratory infections characterised by hoarseness, inspiratory stridor, and a barking cough Exclusion criteria: not reported Baseline characteristics (N = 50):
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Interventions | All children received as routine therapy oxygen, increased humidity, and tetracycline. Treatment (N = 25): 1 mg/kg intramuscular methyl prednisolone every 6 hours for 24 hours Control (N = 25): 1 mg/kg placebo preparation every 6 hours for 24 hours |
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Outcomes | Patient improvement at 6, 12, 24 hours | |
Notes | Funding source: Upjohn Company (supplied drugs for the trial) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The patients were divided into two groups according to a table of random sampling" |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information provided to permit a judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "The composition of each preparation was unknown to the investigators until the end of the study" Comment: described as double‐blind. Investigators blinded, but it is unclear if participants or personnel (or both) were blinded because who administered the treatments is not stated. Subjective outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no description of a third‐party outcome assessor, unclear who performed the measurements. Carried over judgement from blinding of participants and personnel |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 6% (N = 3) lost to follow‐up due to inadequate evaluation. All losses were in 1 group, but it is unclear which group. |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol identified. All prespecified outcomes in the methods appeared in the 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 |