Characteristics of participants according to whether data were included in analysis*
| Characteristic | Participant group; no. (%) of participants† | ||
|---|---|---|---|
| Included in ITT analysis n = 154 | Did not take study drug n = 13 | Withdrew after randomization‡ n = 8 | |
| Age, yr, mean ± SD | 12.4 ± 3.5 | 10.8 ± 3.9 | 12 ± 4.4 |
| Sex, female | 71 (46) | 5 (38) | 4 (50) |
| Group assignment | |||
| Oral morphine§ | 77 (50) | 7 (54) | 4 (50) |
| Ibuprofen | 77 (50) | 6 (46) | 4 (50) |
Note: ITT = intention-to-treat, SD = standard deviation.
↵* Data were included in the analysis if the participant took at least 1 dose of the study medication.
↵† Except where indicated otherwise.
↵‡ Participants who withdrew after randomization but before receiving any study medication.
↵§ One participant in the oral morphine group was excluded from the analysis because the operative case was cancelled by the surgeon after randomization.