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Clinical Trial
. 2004 Oct;48(9):1190-3.
doi: 10.1111/j.1399-6576.2004.00496.x.

Efficacy of oral rofecoxib versus intravenous ketoprofen as an adjuvant to PCA morphine after urologic surgery

Affiliations
Clinical Trial

Efficacy of oral rofecoxib versus intravenous ketoprofen as an adjuvant to PCA morphine after urologic surgery

M C Cabrera et al. Acta Anaesthesiol Scand. 2004 Oct.

Abstract

Background: Adjunctive use of nonsteroidal anti-inflammatory drugs has become increasingly popular in the perioperative period because of their opioid-sparing effects. This randomized, controlled, double-dummy study was designed to evaluate the cost-effectiveness of using oral rofecoxib as an alternative to intravenous ketoprofen for pain management in patients undergoing urologic surgery.

Methods: Seventy patients were randomly assigned to receive either a placebo (Control) or rofecoxib 50 mg po (Rofecoxib) 1 h prior to surgery. After a standardized spinal anesthetic, patients in the Control group received ketoprofen 100 mg IV q 8 h for 24 h, while the Rofecoxib group received an equivolume of saline at 8-h intervals for 24 h. Both groups were allowed to self-administer morphine (1 mg IV boluses) using a PCA delivery system. The need for 'rescue' analgesic medication, as well as pain scores [using an 11-point verbal rating scale (VRS) (0 = none to 10-severe)], were recorded at 1, 2, 6, 12, and 24-h intervals after surgery. In addition, the incidences of side-effects were recorded at the end of the study period.

Results: Total amount of morphine required in the initial 24-h postoperative period was nonsignificantly reduced in the Rofecoxib group (29 +/- 2 vs. 37 +/- 4 mg). More importantly, the percentage of patients reporting moderate-to-severe pain (VRS score > or =4) during the study period was lower in the Rofecoxib group (12 vs. 22%, P < 0.05). The daily cost of rofecoxib (USD 1.14 for 50-mg dose) was also significantly less than ketoprofen (USD 3.06 for three 100-mg doses).

Conclusion: Premedication with oral rofecoxib (50 mg) is a cost-effective alternative to the parenteral nonselective NSAID, ketoprofen (100 mg q 8 h), when used as an adjuvant to PCA morphine for pain management after urologic surgery.

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