Skip to main content
. 2023 Jan 10;2023(1):CD001955. doi: 10.1002/14651858.CD001955.pub5

Alshehr 2005.

Study characteristics
Methods Randomised, double‐blind trial
Participants Study period: September 1998 to December 2002
Setting: emergency rooms and outpatient clinics in 3 medical institutes, Abha City, Saudi Arabia
Inclusion criteria: children aged 3 months to 9 years who had been given a diagnosis of croup and had persistent, moderately severe respiratory distress (Westley croup score > 3)
Exclusion criteria: symptoms or signs suggesting another cause of stridor; history of chronic pulmonary disease; severe systemic disease; immune dysfunction; stridor or intubation for more than 1 month; glucocorticoid therapy in the last 4 weeks before study entry
Baseline characteristics (N = 72):
  • proportion male: treatment: 56%; comparator: 53%

  • mean (SD) age, months: treatment: 16.8 (12); comparator: 17.6 (13)

  • median (range) Westley croup score: treatment: 5.0 (3 to 6); comparator: 4.5 (3 to 6)

Interventions Treatment (N = 36): single dose 0.15 mg/kg oral dexamethasone
Comparator (N = 36): single dose 0.6 mg/kg oral dexamethasone
Outcomes Change in Westley croup score from baseline to 4, 12, and 24 hours; hospitalisation; length of stay in hospital; use of mist tent
Notes All children received mist therapy throughout the observation period.
Funding source: not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A blocked randomization code was produced by random‐number generating software"
Allocation concealment (selection bias) Low risk Quote: "To make the study drugs indistinguishable from each other, they were packaged in opaque containers and diluted on the same amount of solution." "A blocked randomization code was produced ... and the code was not broken until after the study ended and all decisions regarding data analysis were finalized"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "double‐blind" "To make the study drugs indistinguishable from each other, they were packaged in opaque containers and diluted on the same amount of solution."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "double‐blind"; "to make the study drugs indistinguishable from each other, they were packaged in opaque containers and diluted on the same amount of solution"; "the code was not broken until after the study ended and all the decisions regarding data analysis were finalized"
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: 14% (N = 12) of children recruited were excluded prior to randomisation. All randomised children were followed up.
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