Reports from the Field

IV drug reduces need for post-op narcotics

Administration of parecoxib sodium, the first investigational injectable COX-2 specific analgesic, significantly reduced the amount of morphine consumed by patients following total hip replacement surgery while improving overall pain relief, according to results from Phase III, placebo-controlled studies presented at the 20th Annual Scientific Meeting of the American Pain Society held recently in San Francisco.

The study included 175 patients. Patients were assigned randomly to receive a 40 mg dose of parecoxib sodium, a 20 mg dose of parecoxib sodium, or placebo. Those patients receiving parecoxib sodium required 39% less morphine in the 24 hours following hip replacement than placebo-treated patients. Although the overall incidence of adverse events was similar in all groups, significantly fewer patients in the 40 mg parecoxib sodium group reported fever and/or vomiting than did those in the placebo group. These same 40 mg parecoxib sodium patients also scored significantly higher in Pain Intensity Difference scores at most or all assessment points, as well as in measures of overall well-being.

"Surgical pain management all too often requires a compromise between achieving maximum pain control and minimizing side effects," notes principal investigator T. Phillip Malan, MD, associate chair for research in the department for anesthesiology at the University of Arizona Health Science Center in Phoenix. "An agent that could both reduce the need for opioids and improve overall pain relief would be an exciting step toward better acute pain management."

In a second Phase III, multi-center, double-blind study presented at the same APS meeting, the control of pain following total knee replacement was evaluated in 208 patients using single IV doses of parecoxib sodium, morphine, or ketorolac, a traditional nonsteroidal, anti- inflammatory drug (NSAID).

Parecoxib sodium 40 mg provided analgesic efficacy comparable to ketorolac 30 mg and superior to morphine 4 mg at most point times. In addition, 80% of patients who received the 40 mg dose of parecoxib sodium rated their pain medication as good or excellent, compared to 70% of ketorolac patients and 45% of morphine patients.