Koren 1983.
| Methods | Randomised double‐blind controlled trial | |
| Participants |
Study period: January 1979 to January 1980 Setting: paediatric division of the Chaim Sheba Medical Center, Tel Hashomer, Israel Inclusion criteria: children aged from 8 months to 8 years hospitalised with croup (all with inspiratory stridor, dyspnoea, subcostal and/or suprasternal retraction, and a barking cough); informed consent given by the parents Exlcusion criteria: evidence of associated bronchitis, bronchopneumonia, and acute epiglottitis Baseline demographics (N = 78): proportion males:laryngotracheitis (LT) group: treatment: 59%; control: 56%; spasmodic croup (SC) group: treatment: 57%; control: 64% mean age in years, months:LT group: treatment: 2 years, 5 months; control: 2 years, 7 months; SC group: treatment: 2 years, 6 months; control: 2 years, 8 months croup score: not measured |
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| Interventions | Children in all groups were sedated via rectal administration of 75 mg/kg of body weight of chloral hydrate. Treatment (N = 40): single 0.60 mg/kg dose of intramuscular dexamethasone sodium phosphate (4 mg/mL) Control (N = 38): single dose of intramuscular placebo solution of identical appearance |
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| Outcomes | Use of epinephrine and use of antibiotics | |
| 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: "Dexamethasone sodium phosphate and a placebo solution of identical appearance were administered" "All evaluations were completed before the study code was opened" |
| 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 | Low risk | Comment: no missing outcome data |
| 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. |