Geelhoed 1996.
Methods | Randomised double‐blind controlled trial | |
Participants |
Study period: not reported Setting: emergency department of Princess Margaret Hospital for Children, Perth, Australia Inclusion criteria: children older than 3 months presenting to the emergency department with a diagnosis of croup (acute onset of inspiratory stridor, barking cough, hoarseness, and chest wall retractions) not severe enough to warrant admission Exclusion criteria: other acute or chronic medical problems; families that did not have a telephone or had limited English language abilities; received any type of steroids in the preceding week; pre‐existing upper airway condition; history of prolonged stridor; clinical picture that suggested a diagnosis other than croup Baseline demographics (N = 100): proportion male: treatment: 68%; control: 72% mean (SD) age in months: treatment: 37 (23); control: 45 (26) mean croup score: treatment: 0.9; control: 0.9 |
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Interventions | Treatment (N = 50): single 0.15 mg/kg dose of oral dexamethasone Control (N = 50): single dose of oral placebo |
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Outcomes | Reattendance at the emergency department with croup | |
Notes | Funding source: no external funding | |
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 | Quote: "Treatments were given double blind" Comment: no further explanation given. Unclear who was blinded. Subjective outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear 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 | Low risk | Comment: 4% (N = 4) lost to follow‐up. Equal 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. |