Study characteristics |
Methods |
Randomised, double‐blind, placebo‐controlled trial in an emergency department setting in Canada. 1‐month follow‐up |
Participants |
184 children (92 in each group) aged 5 to 16 years (mean 9.74 years) presenting with erythema of the pharynx, onset of symptoms within the previous 48 hours, and 1 chief complaint of sore throat, odynophagia, or dysphagia |
Interventions |
Dexamethasone 0.6 mg/kg orally (maximum of 10 mg) or placebo orally. All participants with a positive direct antigen test for Streptococcus pyogenes group A antigen from pharyngeal swabs were treated with penicillin V. |
Outcomes |
Reduction in pain VAS. Time to onset of pain relief, time to complete pain resolution, percentage recurrence |
Notes |
Analgesia unregulated and unrecorded. Funding source: supported by the Dr Paul HT Thorlakson Foundation Fund. No conflict of interest declared. No contact with study authors. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Block randomisation table with groups of 10 held at a central pharmacy. 2 lists used for those positive and negative on direct antigen testing. Attempted to enrol consecutive children but missed some eligible children when the emergency department was too busy to permit enrolment. |
Allocation concealment (selection bias) |
Low risk |
Placebo with identical appearance and taste used. |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind design. Randomisation code known only pharmacy and not broken until all participants recruited. Outcome assessors blinded to treatment groups. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
5/184 failed to complete. |
Selective reporting (reporting bias) |
Low risk |
Main outcome measures in similar trials included. No outcome measures assessed were not reported. Data and confidence intervals clearly reported. |
Comparability of groups at baseline |
Low risk |
Comparable |