Leipzig 1979.
Study characteristics | ||
Methods | Randomised, double‐blind controlled trial | |
Participants |
Study period: November 1976 to March 1978 Setting: Pediatric Service of the State University Hospital or the Crouse‐Irving Memorial Hospital, Syracuse, NY, USA Inclusion criteria: all children admitted to hospital with a diagnosis of croup with disease of sufficient severity on a predetermined scoring system; consent of the child's physician and parents Exclusion criteria: not reported Baseline demographics (N = 30):
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Interventions | Treatment (N = 16): 2, 0.30 mg/kg doses of intramuscular dexamethasone (4 mg/mL) Control (N = 14): 2 doses of intramuscular placebo (sterile saline) (1 dose initially and another 2 hours later) |
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Outcomes | Change in croup score from baseline to 24 hours; length of stay at hospital; intubation | |
Notes | Funding source: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "assigned from a table of random numbers" |
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: "Vials had been previously prepared containing either dexamethasone (4 mg/L) or sterile saline. They were marked only with a number, assigned from a table of random numbers" Comment: described as double‐blind. Unclear who was blinded and who prepared the vials. Subjective outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Vials had been previously prepared containing either dexamethasone (4 mg/L) or sterile saline. They were marked only with a number, assigned from a table of random numbers" Comment: described as double‐blind. Unclear who was blinded and who prepared the vials. Subjective outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing outcome data |
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 |