Duman 2005.

Methods	Randomised controlled trial
Participants	Study period: September 2002 to September 2003 Setting: paediatric emergency department of Dokuz Eylül University Faculty of Medicine, Izmir, Turkey Inclusion criteria: children aged more than 6 months presenting to the emergency department with a history of inspiratory stridor, barking cough, hoarseness and signs of inspiratory distress, and a Westley croup score of ≥ 2 Exclusion criteria: Westley croup score < 2, and with suggested other causes for stridor (epiglottitis, bacterial tracheitis, foreign body aspiration); past history of laryngoscopy, tracheal intubation, chronic lung disease, or severe comorbidities; immediate intubation or transfer to intensive care; corticosteroid therapy within 4 weeks of presentation; history of tuberculosis personally or in the family; chickenpox within the preceding 21 days; known immunodeficiency Baseline demographics (N = 76): proportion male: treatment 1: 77%; treatment 2: 90%; comparator: 77% mean (SD) age in months: treatment 1: 41.5 (25.5); treatment 2: 43.3 (24.7); comparator: 34.8 (22.4) mean (SD) Westley croup score: treatment 1: 5.3 (1.2); treatment 2: 5.5 (1.8); comparator: 5.0 (1.3)
Interventions	Treatment 1 (N = 31): 2.5 mL (0 to 20 kg) or 5.0 mL (20 to 40 kg) nebulised epinephrine with same volume normal saline and 0.60 mg/kg intramuscular dexamethasone Treatment 2 (N = 19): 2.5 mL (0 to 20 kg) or 5.0 mL (20 to 40 kg) nebulised epinephrine with same volume normal saline and 2 mg nebulised budesonide Comparator (N = 26): cool mist therapy and 0.60 mg/kg intramuscular dexamethasone In all groups, the drug was administered for a period of 20 minutes using a nebuliser with oxygen at a rate of 6 to 7 L/min through a face mask.
Outcomes	Change in Westley croup score from baseline to 2 hours; admissions from the emergency department; use of epinephrine
Notes	Funding source: no external funding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were allocated to treatment according to a randomisation list produced at the beginning of the study. Patients were randomised in blocks of three." Comment: assumed that the blocked randomisation was computer‐generated
Allocation concealment (selection bias)	Unclear risk	Comment: insufficient information provided to judge.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: no blinding. Subjective outcomes
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: no blinding. No description of a third‐party outcome assessor. Subjective outcomes
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	High risk	Comment: at least 1 domain judged as high risk.