| Methods |
Randomised controlled, double‐blind trial |
| Participants |
Children > 2 years old enrolled May 1984 to February 1985 in Illinois, US |
| Interventions |
Amoxicillin 100 mg x 1 dose followed by placebo 3 times daily for 10 days
versus
placebo x 1 dose followed by amoxicillin 40 mg/kg 3 times daily for 10 days |
| Outcomes |
Absence of fever and otalgia, decreased irritability and improved appearance of tympanic membrane at 48 to 72 hours and 10 to 14 days after study entry |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Blinding (performance bias and detection bias)
Treatment failure at 1 month or less |
Low risk |
|
| Incomplete outcome data (attrition bias)
Treatment failure at 1 month or less |
Low risk |
|
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
High risk |
Stopped early with small sample size due to treatment failures in experimental group, funding not reported |
