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. 2023 Jan 10;2023(1):CD001955. doi: 10.1002/14651858.CD001955.pub5

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):
  • proportion male: not reported

  • age: not reported

  • croup score: not reported

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
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