Table 1 Baseline characteristics of the per-protocol study population
Patient and surgery characteristics | Tapentadol (n = 133) | Oxycodone/Naloxone (n = 131) | Total (n = 264) |
|---|---|---|---|
Study site | |||
1 | 65 (49%) | 65 (50%) | 130 (49%) |
2 | 68 (51%) | 66 (50%) | 134 (51%) |
Age (in years) | 60 ± 19 | 59 ± 19 | 59 ± 19 |
Female sex | 86 (65%) | 83 (64%) | 169 (64%) |
Smoker | 27 (20%) | 26 (20%) | 53 (20%) |
BMI (in kg/m2) | 27 ± 6 | 26 ± 5 | 27 ± 5 |
Number of risk factors for PONV | |||
1 | 16 (12%) | 14 (11%) | 30 (11%) |
2 | 38 (29%) | 43 (33%) | 81 (31%) |
3 | 61 (46%) | 56 (43%) | 117 (44%) |
4 | 18 (14%) | 18 (14%) | 36 (14%) |
Prophylaxis of PONV | |||
None | 49 (37%) | 56 (43%) | 105 (40%) |
Single | 56 (42%) | 50 (38%) | 106 (40%) |
Double | 27 (20%) | 25 (19%) | 52 (20%) |
Triple | 1 (0.8%) | 0 (0.0%) | 1 (0.4%) |
Type of surgery | |||
Open reduction and internal fixation (ORIF) | 103 (77%) | 98 (75%) | 201 (76%) |
Closed reposition and intramedullary nailing | 10 (8%) | 9 (7%) | 19 (7%) |
Joint replacement | 9 (7%) | 14 (11%) | 23 (9%) |
Reconstruction of ligaments and muscle | 10 (8%) | 10 (8%) | 20 (8%) |
Fixateur externe | 1 (0.8%) | 0 (0.0%) | 1 (0.4%) |
Duration of surgery (in minutes) | 78 ± 41 | 78 ± 43 | 78 ± 42 |