Martinez Fernandez 1993.
Methods | Randomised double‐blind controlled trial | |
Participants |
Study period: October 1989 to September 1990 Setting: Children's Hospital in Spain Inclusion criteria: children hospitalised with symptoms suggestive of croup (acute laryngitis, laryngotracheobronchitis, spasmodic croup) Exclusion criteria: child's croup judged by the physician to be too severe Baseline characteristics (N = 66): proportion males: not reported age: not reported mean (SD) croup score: treatment 1: 3.5 (1.7); treatment 2: 2.9 (1.4); treatment 3: 3.3 (1.1); control: 3.2 (1.5) |
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Interventions | Treatment 1 (N = 15): single dose of intramuscular placebo, plus 0.14% nebulised L‐epinephrine initially and every 4 hours as needed Treament 2 (N = 16): single 0.5 mg/kg dose of intramuscular dexamethasone, plus nebulised placebo (saline) initially and every 4 hours as needed Treatment 3 (N = 18): single 0.5 mg/kg dose of intramuscular dexamethasone, plus 0.14% nebulised L‐epinephrine initially and every 4 hours as needed Control (N = 17): single dose of intramuscular placebo, plus nebulised placebo (saline) initially and every 4 hours as needed All children received humidified oxygen and fluid therapy. |
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Outcomes | Change in croup score from baseline to 6, 12, and 24 hours | |
Notes | Written in Spanish; 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) | Low risk | Comment: treatments shipped in pre‐numbered ampoules, unlabeled and randomly ordered by the pharmacy. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: described as double‐blind. Treatments shipped in pre‐numbered ampoules, unlabeled and randomly ordered by the pharmacy. |
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. |