BACKGROUND: The parenteral cyclo-oxygenase, or COX, -2 selective inhibitor parecoxib sodium in a 40-milligram dose for intravenous/intramuscular, or i.v./i.m., administration is approved for postoperative pain in Europe, but not yet in the United States. However, previous trials in dental surgical patients have indicated that lower doses may be as effective. METHODS: The authors enrolled 353 patients in a single-center, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and tolerability of single i.m. doses of parecoxib (1-20 mg) with ketorolac tromethamine 30 mg i.m. after dental surgery. Pain assessments occurred at baseline and through 24 hours postdose. RESULTS: A 20-mg dose of parecoxib was significantly more effective than were 1-mg to 10-mg doses and than placebo. The analgesic onset of a 20-mg dose of parecoxib was similar to that of a 30-mg dose of ketorolac. The magnitude of analgesia with a 20-mg dose of parecoxib was significantly lower than that with ketorolac, according to the mean pain intensity difference, or PID, scores from one and one-half to four hours postdose or summed PID, or SPID, -categorical scores at six hours postdose. However, there was no significant difference in mean pain relief; total pain relief, or TOTPAR; and SPID-visual analog scale, or VAS, scores six hours postdose. Mean PID scores for parecoxib 20 mg from 12 to 24 hours postdose were significantly higher than and SPID-VAS mean scores were not statistically significantly different from eight hours onward. CONCLUSIONS:Parecoxib 20 mg i.m. is an effective analgesic dose with an onset and magnitude of analgesic effect approaching that of ketorolac 30 mg i.m. after dental surgery. It also is well-tolerated. CLINICAL IMPLICATIONS: These findings support the use of parecoxib 20 mg i.m. as an initial dosing option for postoperative pain management in countries in which it is approved.
RCT Entities:
BACKGROUND: The parenteral cyclo-oxygenase, or COX, -2 selective inhibitor parecoxib sodium in a 40-milligram dose for intravenous/intramuscular, or i.v./i.m., administration is approved for postoperative pain in Europe, but not yet in the United States. However, previous trials in dental surgical patients have indicated that lower doses may be as effective. METHODS: The authors enrolled 353 patients in a single-center, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and tolerability of single i.m. doses of parecoxib (1-20 mg) with ketorolac tromethamine 30 mg i.m. after dental surgery. Pain assessments occurred at baseline and through 24 hours postdose. RESULTS: A 20-mg dose of parecoxib was significantly more effective than were 1-mg to 10-mg doses and than placebo. The analgesic onset of a 20-mg dose of parecoxib was similar to that of a 30-mg dose of ketorolac. The magnitude of analgesia with a 20-mg dose of parecoxib was significantly lower than that with ketorolac, according to the mean pain intensity difference, or PID, scores from one and one-half to four hours postdose or summed PID, or SPID, -categorical scores at six hours postdose. However, there was no significant difference in mean pain relief; total pain relief, or TOTPAR; and SPID-visual analog scale, or VAS, scores six hours postdose. Mean PID scores for parecoxib 20 mg from 12 to 24 hours postdose were significantly higher than and SPID-VAS mean scores were not statistically significantly different from eight hours onward. CONCLUSIONS:Parecoxib 20 mg i.m. is an effective analgesic dose with an onset and magnitude of analgesic effect approaching that of ketorolac 30 mg i.m. after dental surgery. It also is well-tolerated. CLINICAL IMPLICATIONS: These findings support the use of parecoxib 20 mg i.m. as an initial dosing option for postoperative pain management in countries in which it is approved.