Proportion of patients achieving FPPAR, confirmed FPPAR and MPAR at prespecified time interval of 30 min, 1 hour and 2 hours using stopwatch (ITT population)
| Parameter | Time interval | Responder | TRAM/DKP n=260, (%) | TRAM/paracetamol n=262, (%) | Placebo n=131, (%) | Statistical test TRAM/DKP versus TRAM/paracetamol (p value) |
| FPPAR | 30 min | Yes | 207 (79.6) | 184 (70.2) | 66 (50.4) | 0.0134 |
| No | 53 (20.4) | 78 (29.8) | 65 (49.6) | |||
| 1 hour | Yes | 243 (93.5) | 227 (86.6) | 79 (60.3) | 0.0093 | |
| No | 17 (6.5) | 35 (13.4) | 52 (39.7) | |||
| 2 hours | Yes | 247 (95.0) | 231 (88.2) | 80 (61.1) | 0.0050 | |
| No | 13 (5.0) | 31 (11.8) | 51 (38.9) | |||
| Confirmed FPPAR | 30 min | Yes | 200 (76.9) | 158 (60.3) | 26 (19.8) | <0.0001 |
| No | 60 (23.1) | 104 (39.7) | 105 (80.2) | |||
| 1 hour | Yes | 234 (90.0) | 190 (72.5) | 32 (24.4) | <0.0001 | |
| No | 26 (10.0) | 72 (27.5) | 99 (75.6) | |||
| 2 hours | Yes | 235 (90.4) | 191 (72.9) | 33 (25.2) | <0.0001 | |
| No | 25 (9.6) | 71 (27.1) | 98 (74.8) | |||
| MPAR | 30 min | Yes | 99 (38.1) | 71 (27.1) | 6 (4.6) | 0.0075 |
| No | 161 (61.9) | 191 (72.9) | 125 (95.4) | |||
| 1 hour | Yes | 205 (78.8) | 165 (63.0) | 17 (13.0) | <0.0001 | |
| No | 55 (21.2) | 97 (37.0) | 114 (87.0) | |||
| 2 hours | Yes | 235 (90.4) | 191 (72.9) | 33 (25.2) | <0.0001 | |
| No | 25 (9.6) | 71 (27.1) | 98 (74.8) |
FPPAR, first perceptible pain relief; ITT, intention to treat; MPAR, meaningful pain relief; TRAM/DKP, tramadol/dexketoprofen.