Methods |
RCT |
Participants |
57 children, mean age 4.7 years (range 18 months to 12 years), 53% boys, 82% white, private practices, USA, night cough due to URTI |
Interventions |
Antitussive: dextromethorphan 15 mg/5 ml and codeine 10 mg/ 5 mg as a single dose at bedtime for 3 nights |
Outcomes |
Parent questionnaire, cough score from 0 to 4 |
Notes |
Both active treatments also contained guaifenesin 100 mg/5 ml. Adverse effects mainly drowsiness, diarrhoea and hyperactivity: placebo 7/13 (54%), dextromethorphan 6/19 (32%, P value = 0.2) and codeine 5/17 (29%, P value = 0.8) |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not reported |
Allocation concealment (selection bias) |
Unclear risk |
Not reported |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Patients and providers blinded; outcome assessor blinding not reported |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
86% follow‐up; difference between groups not reported |
Selective reporting (reporting bias) |
Unclear risk |
Not reported |
Other bias |
Unclear risk |
Post hoc power calculation demonstrates that study was powered to detect a difference of 0.9 in cough score, which is equivalent to natural resolution of cough at day 3. Authors argue that smaller reductions in cough scores are unlikely to be clinically important |