Study characteristics |
Methods |
Prospective, randomised, double‐blind, placebo‐controlled trial in an emergency department setting in the USA. Follow‐up until resolution of pain, longest contact with participant for follow‐up was 87 hours. |
Participants |
150 children (75 each group) aged 5 to 18 years (mean 11.9 years) with odynophagia or dysphagia, moderate to severe pharyngeal erythema or swelling as determined by the emergency department physician, and McGrath Facial Affective Scale (FAS) score of 'F' (0.75) or higher were randomised. |
Interventions |
Dexamethasone 0.6 mg/kg orally single dose or oral isotonic sodium chloride solution as placebo. Antibiotics (penicillin G IM, amoxicillin or azithromycin orally) given if rapid streptococcal antigen test positive or culture positive for group A beta‐haemolytic streptococcus. |
Outcomes |
Reduction in McGrath FAS score. Time to onset of pain relief. Time to complete pain resolution. Fever. Associated symptoms. Need for further medical care |
Notes |
Analgesia use recorded. Convenience sample of participants. Funding source/declaration of interest: not declared. No contact with study authors. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Block randomisation using a computerised random numbers table in groups of 30 |
Allocation concealment (selection bias) |
Low risk |
Both steroid and placebo medications flavoured and coloured with cherry syrup. |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind design, although specific blinding not reported |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
25/150 lost to follow‐up. |
Selective reporting (reporting bias) |
Low risk |
Abstract published 2 years earlier did not report any additional outcomes. |
Comparability of groups at baseline |
Unclear risk |
Comparable |