Summary of descriptive statistics TOTPAR, % max TOTPAR SPID and % max SPID over 2, 4, 6 and 8 hours
| Parameter | Time points | TRAM/DKP n=260 | TRAM/ paracetamol n=262 | Placebo n=131 | Statistical test TRAM/DKP versus TRAM/paracetamol |
| Mean (SD) | Mean (SD) | Mean (SD) | P value | ||
| TOTPAR | 2 hours | 4.6 (1.99) | 3.3 (2.19) | 0.8 (1.22) | <0.0001 |
| 4 hours | 9.5 (4.47) | 6.5 (4.95) | 1.5 (2.71) | <0.0001 | |
| 6 hours (primary endpoint) | 13.0 (6.97) | 9.2 (7.65) | 1.9 (3.89) | <0.0001 | |
| 8 hours | 15.3 (9.22) | 11.3 (10.15) | 2.4 (5.23) | <0.0001 | |
| % max TOTPAR | 2 hours | 51.5 (22.08) | 36.7 (24.29) | 9.1 (13.56) | <0.0001 |
| 4 hours | 56.1 (26.32) | 38.1 (29.11) | 8.8 (15.95) | <0.0001 | |
| 6 hours | 51.9 (27.87) | 36.6 (30.62) | 7.7 (15.57) | <0.0001 | |
| 8 hours | 46.5 (27.95) | 34.2 (30.76) | 7.1 (15.86) | <0.0001 | |
| SPID | 2 hours | 6.4 (3.57) | 4.1 (3.57) | 0.3 (2.38) | <0.0001 |
| 4 hours | 13.6 (7.49) | 8.2 (7.63) | 1.1 (4.57) | <0.0001 | |
| 6 hours | 18.4 (11.09) | 11.7 (11.58) | 1.6 (6.72) | <0.0001 | |
| 8 hours | 21.5 (14.27) | 14.4 (15.21) | 2.2 (8.98) | <0.0001 | |
| % max SPID | 2 hours | 56.1 (27.31) | 38.1 (32.05) | 2.4 (23.07) | <0.0001 |
| 4 hours | 59.4 (29.03) | 38.7 (34.87) | 4.7 (21.93) | <0.0001 | |
| 6 hours | 53.6 (30.14) | 36.8 (35.27) | 4.9 (21.58) | <0.0001 | |
| 8 hours | 47.2 (29.62) | 34.1 (34.89) | 5.2 (21.48) | <0.0001 |
Statistical test performed to compare active treatments only (ITT population).
ITT, intention to treat; SPID, sum of pain intensity difference; TOTPAR, total pain relief; TRAM/DKP, tramadol/dexketoprofen.