Table 2.
Time period by dataset | Mean SPI/mm • hour (standard deviation) | Mean TOpA/mg IV morphine eq. (standard deviation) | I-SPI-TOpA | ||||
---|---|---|---|---|---|---|---|
|
|
|
|||||
Treatment | Control | P value | Treatment | Control | P value | P value | |
24 hours post time 0 | |||||||
Study 1 | 670 (401) | 1191 (602) | <0.001* | 18.5a (12.6) | 24.6 (15.3) | 0.123a | 0.013* |
Study 2 | 996 (504) | 1270 (567) | 0.080 | 20.6 (19.9) | 36.9 (17.6) | 0.004* | 0.005* |
Pooledb | 833 | 1231 | <0.001* | 19.5 | 30.8 | 0.001* | <0.0001* |
48 hours post time 0 | |||||||
Study 1 | 1351 (857) | 2130 (1228) | 0.012* | 30.6a (19.9) | 36.5 (25.5) | 0.359a | 0.097 |
Study 2 | 2018 (1093) | 2457 (1157) | 0.178 | 36.3 (34.7) | 56.4 (32.8) | 0.042* | 0.039* |
Pooledb | 1684 | 2293 | 0.006* | 33.4 | 46.5 | 0.024* | 0.008* |
72 hours post time 0 | |||||||
Study 1 | 1864 (1239) | 2838 (1807) | 0.030* | 37.2a (29.3) | 44.9 (35.0) | 0.396a | 0.136 |
Study 2 | 2842 (1722) | 3485 (1807) | 0.184 | 48.7 (46.1) | 70.8 (44.3) | 0.0940.078 | |
Pooledb | 2337 | 3161 | 0.014* | 42.9 | 57.8 | 0.058 | 0.021* |
Notes:
Includes patient in the treatment group that reported taking morphine rescue medication as maximally allowed and not according to need for pain relief;
for the pooled data, least squared means are reported and are based on the analysis of variance model that included fixed effects for treatment, study/dose, and treatment-by-study interaction;
statistically significant (P ≤ 0.05).
Abbreviations: IV, intravenous; eq, equivalents; SPI, summed pain intensity; TOpA, total opioid analgesia; I-SPI-TOpA, integrated endpoint of summed pain intensity and total opioid analgesia.