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

Cruz 1995.

Methods Randomised double‐blind controlled trial
Participants Study period: November 1992 to December 1993
Setting: emergency department at the Children's Hospital of Michigan, USA
Inclusion criteria: children aged 6 months to 5 years reporting to the emergency department with a clinical diagnosis of acute laryngotracheitis or viral croup. Westley croup score of at least 2 and able to be managed as outpatients
Exclusion criteria: history of prior intubation; structural airway anomalies; those requiring more than 1 racemic epinephrine treatment; hospitalisation; β‐agonist therapy; received steroids in the past 24 hours
Baseline demographics (N = 45):
proportion male: treatment: 74%; control: 63%
median (SD) age in months: treatment: 18.0 (19.0); control: 21.0 (8.0)
median (range) Westley croup score: treatment: 3 (2 to 5); control: 3 (2 to 5)
Interventions Treatment (N = 19): single 0.60 mg/kg (maximum 10 mg) dose of intramuscular dexamethasone
Control (N = 19): equal volume of placebo (normal saline)
Outcomes Return visits to the emergency department; patient improvement 24 hours after discharge
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: "double blind" "Both the patients and the investigators were blinded to the content of the syringe" "the drug code was broken only after the last patient had completed the study"
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 Unclear risk Comment: 16% (N = 7) were excluded or lost to follow‐up, unclear if losses were balanced between groups.
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.