Cruz 1995.
Methods | Randomised double‐blind controlled trial | |
Participants |
Study period: November 1992 to December 1993 Setting: emergency department at the Children's Hospital of Michigan, USA Inclusion criteria: children aged 6 months to 5 years reporting to the emergency department with a clinical diagnosis of acute laryngotracheitis or viral croup. Westley croup score of at least 2 and able to be managed as outpatients Exclusion criteria: history of prior intubation; structural airway anomalies; those requiring more than 1 racemic epinephrine treatment; hospitalisation; β‐agonist therapy; received steroids in the past 24 hours Baseline demographics (N = 45): proportion male: treatment: 74%; control: 63% median (SD) age in months: treatment: 18.0 (19.0); control: 21.0 (8.0) median (range) Westley croup score: treatment: 3 (2 to 5); control: 3 (2 to 5) |
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Interventions | Treatment (N = 19): single 0.60 mg/kg (maximum 10 mg) dose of intramuscular dexamethasone Control (N = 19): equal volume of placebo (normal saline) |
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Outcomes | Return visits to the emergency department; patient improvement 24 hours after discharge | |
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 | Low risk | Quote: "double blind" "Both the patients and the investigators were blinded to the content of the syringe" "the drug code was broken only after the last patient had completed the study" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: no description of a third‐party outcome assessor. Carried over judgement from blinding of participants and personnel |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 16% (N = 7) were excluded or lost to follow‐up, unclear if losses were balanced between groups. |
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. |