Table 3.
Statistical analysis of SPID at rest during 2, 4, 6, 24, and 48 h (analysis of covariance; all randomized patients). DKP, dexketoprofen trometamol 25 mg; DKP/TRAM, dexketoprofen trometamol/tramadol hydrochloride 25 mg/75 mg; se, standard error; SPIDn, sum of the pain intensity differences during ‘n’ hours after the first dose; TRAM, tramadol hydrochloride 100 mg
| Time points |
Point estimate (se) (Treatment A) | Point estimate (se) (Treatment B) | Estimated treatment difference (se) (Treatment A−B) | 95% Confidence interval | P-value | |
|---|---|---|---|---|---|---|
| Treatment A | Treatment B | |||||
| SPID2 at rest | ||||||
| DKP/TRAM | DKP | 52 (2.7) | 44 (2.7) | 7.9 (3.8) | 0.4–16 | 0.038 |
| DKP/TRAM | TRAM | 52 (2.7) | 47 (2.7) | 5.7 (3.8) | −1.8 to 13 | 0.136 |
| DKP | Placebo | 44 (2.7) | 40 (2.7) | 4.1 (3.8) | −3.4 to 12 | 0.282 |
| TRAM | Placebo | 47 (2.7) | 6.4 (3.8) | 6.4 (3.8) | −1.2 to 14 | 0.097 |
| SPID4 at rest | ||||||
| DKP/TRAM | DKP | 124 (5.8) | 103 (5.8) | 22 (8.2) | 5.9–38 | 0.008 |
| DKP/TRAM | TRAM | 124 (5.8) | 105 (5.8) | 19 (8.2) | 3.2–35 | 0.019 |
| DKP | Placebo | 103 (5.8) | 85 (5.8) | 18 (8.2) | 1.7–34 | 0.030 |
| TRAM | Placebo | 105 (5.8) | 85 (5.8) | 20 (8.2) | 4.4–36 | 0.013 |
| SPID6 at rest | ||||||
| DKP/TRAM | DKP | 191 (8.9) | 158 (8.8) | 33 (13) | 8.1–57 | 0.009 |
| DKP/TRAM | TRAM | 191 (8.9) | 159 (8.8) | 32 (13) | 7.5–57 | 0.011 |
| DKP | Placebo | 158 (8.8) | 120 (8.8) | 38 (13) | 14–63 | 0.002 |
| TRAM | Placebo | 159 (8.8) | 120 (8.8) | 39 (13) | 14–63 | 0.002 |
| SPID24 at rest | ||||||
| DKP/TRAM | DKP | 929 (34) | 752 (34) | 177 (48) | 82–271 | <0.001 |
| DKP/TRAM | TRAM | 929 (34) | 827 (34) | 102 (48) | 8.1–197 | 0.033 |
| SPID48 at rest | ||||||
| DKP/TRAM | DKP | 1949 (65) | 1674 (65) | 274 (92) | 93–455 | 0.003 |
| DKP/TRAM | TRAM | 1949 (65) | 1771 (65) | 178 (92) | −2.8 to 359 | 0.054 |