Monday, November 4, 2002 - 5:12 PM

Rofecoxib--A Specific Cox-2 Inhibitor For the Treatment of Pain After Breast Augmentation: A Randomized, Placebo-Controlled Clinical Trial

Gilles N. Beauregard, MD, Pierre Duguay, MD, and Manon Choiniere, PhD.

INTRODUCTION AND OBJECTIVES: Nonsteroidal anti-inflammatory drugs (NSAIDs) are recommended for the multimodal management of postoperative pain and they may have a significant opioid sparing effect after surgery. However, the use of NSAIDs in plastic surgery is generally avoided because of the risk of intraoperative bleeding and hematoma. The development of specific COX-2 inhibitors such as rofecoxib represents an interesting option as they have been shown to provide effective postoperative analgesia with less risk of bleeding complications. This study was designed to assess the efficacy and safety of rofecoxib for controlling pain after breast augmentation. METHODS: This randomized, double-blind, placebo-controlled study was carried out in 77 patients aged between 19 and 43 yr (26.7 6.2) who were scheduled for bilateral submuscular breast augmentation. Patients were randomly assigned to receive rofecoxib 50 mg or a placebo pill one hour before surgery, and once a day for seven days. Efficacy outcomes included rescue opioid intake and postoperative pain severity. Pain intensity at rest and on movement was measured at frequent intervals with a standardised 0 - 10 pain scale. The Brief Pain Inventory (Cleeland & Ryan 1994) was administered to assess the impact pain on various aspects of daily functioning. Various adverse drug effects were also measured including intraoperative bleeding and incidence of hematoma. RESULTS: There was no demographic difference between the Rofecoxib (R) (N=38) and Placebo (P) group (n=39). IV morphine requirements in the immediate postoperative period was significantly lower in the R-Group compared to the P-Group (p=.05). Intake of codeine in combination with acetaminophen in the 7 days following surgery was also significantly reduced in the R-Group (p=.01). Postoperative pain intensity scores both at rest and with effort were similar for both groups. Impact of pain on various aspects of daily functioning was also comparable in the two groups. No significant differences were observed for the incidence of adverse effects except for the frequency of nausea which was slightly but significantly higher in the R-Group (p=.04). CONCLUSIONS: It is concluded that rofecoxib is a useful and effective agent for pain treatment after breast augmentation as revealed by its opioid sparing effects and its safety profile in terms of bleeding complications. The usefulness of selective COX-2 inhibitors such as rofecoxib certainly merits further investigation for other types of interventions as they represent an interesting therapeutic avenue for pain control in plastic surgery.
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