Table 2.
Demographic Data And Baseline Characteristics
| Placebo N=52 |
Tapentadol N=108 |
Overall N=160 |
|
|---|---|---|---|
| Sex | |||
| Female | 23 (44.2%) | 53 (49.1%) | 76 (47.5%) |
| Male | 29 (55.8%) | 55 (50.9%) | 84 (52.5%) |
| Age group | |||
| 2 to <6 years | 12 (23.1%) | 23 (21.3%) | 35 (21.9%) |
| 6 to <12 years | 15 (28.8%) | 32 (29.6%) | 47 (29.4%) |
| 12 to <18 years | 25 (48.1%) | 53 (49.1%) | 78 (48.8%) |
| Body mass index (kg/m2) | 19.1±3.8 | 18.8±4.1 | 18.9±4.0 |
| Duration of surgery (min) | 203.9±155.8 | 186.0±110.5 | 191.9±126.8 |
| Background infusiona | 15 (28.8%) | 39 (36.1%) | 54 (33.8%) |
| Intake of morphine or hydromorphone in the 24 hrs prior to trial medication (mg/kgb) | 0.45±0.7 | 0.59±1.2 | 0.55±1.1 |
| Time between end of surgery and first dose of trial medication (min) | 795.9±553 | 1018.9±1483.8 | 946.5±1261.3 |
Notes: Data are mean±standard deviation or number of patients (%). aMorphine or hydromorphone; bmorphine equivalents.