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. 2018 Aug 22;2018(8):CD001955. doi: 10.1002/14651858.CD001955.pub4

Geelhoed 1995b.

Methods Randomised double‐blind controlled trial (trial B; see Geelhoed 1995a for trial A)
Participants Study period: August 1994 to December 1994
Setting: Princess Margaret Hospital for Children, Perth, Australia
Inclusion criteria: children older than 3 months admitted to the hospital with a diagnosis of croup (acute onset of inspiratory stridor, chest wall retractions, barking cough, and hoarse voice) and a minimum modified Westley croup score of 3
Exclusion criteria: other acute or chronic medical problems; modified Westley croup score < 3 (mild croup); families without a telephone or with limited English language abilities; any kind of steroid therapy in the past week; pre‐existing upper airway condition; history of prolonged stridor; those presenting with a clinical picture suggesting a diagnosis other than croup; admitted directly to the intensive care unit with severe croup
Baseline demographics (N = 60):
proportion male: treatment: 90%; control: 74%
mean (SD) age in months: treatment: 38 (34); comparator: 32 (23)
mean modified Westley croup score: treatment: 4.0; comparator: 3.7
Interventions Treatment (N = 29): single 0.15 mg/kg (maximum 3 mg) dose of oral dexamethasone
Comparator (N = 31): single 0.30 mg/kg (maximum 6 mg) dose of oral dexamethasone
Outcomes Change in modified Westley croup score from baseline to 2 and 4 hours; re‐presentations with croup; length of hospital stay; use of epinephrine and use of additional glucocorticoids
Notes Study reports on 2 comparisons. 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 All outcomes Unclear risk Quote: "treatments were administered in a double blind fashion" "If the child was withdrawn from the study, their study code was broken."
Comment: described as double‐blind. Unclear who was blinded. Code could be broken, but unclear how frequently this occurred. 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: intention‐to‐treat analysis used. 8% (N = 5) in trial B lost to follow‐up
Selective reporting (reporting bias) Unclear risk Comment: no protocol identified. All prespecified outcomes from methods appear in results.
Other bias Unclear risk Comment: some children were not enrolled when the emergency department was busy, potential to bias participant selection.
Overall risk of bias 
 All outcomes Unclear risk Comment: at least 1 domain judged as unclear risk, and no domains judged as high risk.