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. 2012 Jun 27;5:217–225. doi: 10.2147/JPR.S33453

Table 2.

Results for SPI, TOpA, and I-SPI-TOpA through 24, 48, and 72 hours for study 1, study 2, and pooled dataset

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:

a

Includes patient in the treatment group that reported taking morphine rescue medication as maximally allowed and not according to need for pain relief;

b

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.