Primary outcome, mean ear pain score over first 3 days
| Intervention (N= 94) | Usual care (N= 129) | Effect estimate | ||
|---|---|---|---|---|
| Analysis | n | Mean (95% CI) | Mean (95% CI) | Mean difference (95% CI) |
| Intention-to-treat | ||||
| Over first 3 days | ||||
| Crude | 210 | 4.66 (4.23 to 5.08) | 4.36 (3.99 to 4.73) | 0.16 (−0.55 to 0.88) |
| Adjusteda | 138 | −0.05 (−0.93 to 0.83) | ||
| Per day | ||||
| Day 0 (at inclusion) | 7.20 (6.66 to 7.73) | 7.03 (6.57 to 7.49) | ||
| Day 1 | 5.15 (4.61 to 5.68) | 4.70 (4.23 to 5.16) | ||
| Day 2 | 3.69 (3.15 to 4.22) | 3.27 (2.91 to 3.74) | ||
| Day 3 | 2.60 (2.06 to 3.14) | 2.43 (1.97 to 2.90) | ||
| Sensitivity analysis: imputation for baseline variables (including confounders) | ||||
| Adjusteda | 223 | 0.03 (−0.68 to 0.73) | ||
| Sensitivity analysis: imputation for baseline and outcome variables (including confounders) | ||||
| Adjusteda | 223 | 0.01 (−0.78 to 0.79) | ||
↵a Adjusted for: sex, age, unilateral versus bilateral acute otitis media, ill appearance, number of days ear pain prior to consultation, ear pain at inclusion, otorrhea at inclusion, fever at inclusion, history of recurrent otitis media, oral antibiotic prescriptions (immediate).