Husby 1993.
Study characteristics | ||
Methods | Randomised, double‐blind controlled trial | |
Participants |
Study period: October 1990 to December 1991 Setting: Department of Paediatrics, Kolding Hospital, Denmark Inclusion criteria: children admitted to hospital with croup (inspiratory stridor, cough, and respiratory distress) with a modified Westley croup score > 5 and informed parental consent Exclusion criteria: clinical condition consistent with epiglottitis, foreign body aspiration, bronchiolitis, or asthma; received local or systemic steroid treatment or epinephrine Baseline demographics (N = 36) (1 child excluded before placebo was administered):
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Interventions | Treatment (N = 20): 2, 1000 µg (2 mL 500 µg/mL) doses of nebulised budesonide, 30 minutes apart Control (N = 16): 2, 2 mL doses of placebo (0.9% saline), 30 minutes apart Both treatment and placebo were given with a dynamic flow rate of 8 L/min. |
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Outcomes | Change in modified Westley croup score from baseline to 2 hours; 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 permit a judgement |
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 | Comment: described as double‐blind, no further explanation. Insufficient information provided to permit a judgement. |
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: 1 child omitted as did not receive treatment due to technical problems. No other 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 |