Background and objective: Data on the effectiveness of cyclooxygenase 2 inhibitors in postoperative pain therapy vary widely. We tested in a prospective, placebo-controlled, randomized, double-blind trial the hypotheses that perioperative (i.e. preoperative and postoperative) administration of the cyclooxygenase 2 inhibitor rofecoxib decreases pain scores and morphine consumption after spine, breast and orthopaedic surgery.
Methods: Five hundred and forty patients scheduled for spine, breast or orthopaedic surgery were randomly assigned to receive in combination with postoperative morphine via patient controlled analgesia pump for 4 days either rofecoxib 50 mg administered perioperatively, rofecoxib 50 mg administered only postoperatively, or placebo. Primary outcome criteria were pain score at rest (numeric rating scale 0-4) and morphine consumption.
Results: Perioperative rofecoxib significantly decreased pain score 0 (0-1) vs. 1 (0-2) (median (interquartile range)), and morphine consumption 18 (6-33) vs. 22.5 (12-38) compared with placebo. In contrast, rofecoxib when administered only postoperatively did not significantly improve analgesic effects or side-effects at time of assessment of the main criteria (24 h after skin closure), but during the follow-up period at 48 h and 72 h after skin closure pain scores and morphine consumption were improved compared to placebo. The analgesic effects of rofecoxib were independent from the type of surgery.
Conclusions: Perioperative administration of the cyclooxygenase 2 inhibitor rofecoxib decreases pain scores and morphine consumption after orthopaedic, breast and spine surgery. However, the benefit of preoperative administration of the cyclooxygenase 2 inhibitor seems to be only moderate, suggesting that early postoperative administration may be a useful alternative approach. There is no evidence that the type of surgery influences analgesic effects of cyclooxygenase 2 inhibitors.