BACKGROUND: The analgesic efficacy and side effect profile of intravenous parecoxib, a novel cyclooxygenase type-2 (COX-2) inhibitor, was assessed in a double-blinded, placebo-controlled study involving patients undergoing major gynecologic surgical procedures. METHODS: After Institutional Review Board approval, 60 consenting women, American Society of Anesthesiologists (ASA) physical status I-III, undergoing lower abdominal surgery with a standardized general anesthetic technique were randomly assigned to receive one of three study medications: group 1 (control) received normal saline; group 2 received intravenous parecoxib, 20 mg; and group 3 received intravenous parecoxib, 40 mg. The initial dose of study medication was administered when the patient first requested pain medication after surgery. All patients had access to patient-controlled analgesia (PCA) with intravenousmorphine, 1 or 2 mg, with a 6-min lockout period. Subsequent doses of the same study medication were administered at 12-h and 24-h intervals after the initial dose. The postoperative opioid analgesic requirement (PCA morphine usage), pain scores, pain relief scores, side effects, and need for supplemental medications (e.g., antiemetics, antipruritics, laxatives) were recorded. RESULTS: Compared with saline, intravenous parecoxib, 20 mg and 40 mg every 12 h, significantly decreased the PCA morphine usage during the first 6 h postoperatively (group 1, 25 +/- 13 mg; group 2, 16 +/- 11 mg; group 3, 17 +/- 10 mg) and at 12 h (group 1, 34 +/- 18 mg; group 2, 24 +/- 14 mg; group 3, 23 +/- 13 mg) and 24 h (group 1, 51 +/- 27 mg; group 2, 34 +/- 20 mg; group 3, 33 +/- 21 mg) after surgery. However, there were no significant differences in the patients' global evaluation of the study medications at 12 h and 24 h between those who received intravenous parecoxib (20 or 40 mg) and saline. Moreover, the postoperative pain scores and side effect profiles were similar in the three treatment groups. CONCLUSION:Intravenous parecoxib (20 or 40 mg) was effective in decreasing the PCA opioid requirement after lower abdominal surgical procedures. However, it failed to improve pain management or reduce opioid-related side effects in the early postoperative period.
RCT Entities:
BACKGROUND: The analgesic efficacy and side effect profile of intravenous parecoxib, a novel cyclooxygenase type-2 (COX-2) inhibitor, was assessed in a double-blinded, placebo-controlled study involving patients undergoing major gynecologic surgical procedures. METHODS: After Institutional Review Board approval, 60 consenting women, American Society of Anesthesiologists (ASA) physical status I-III, undergoing lower abdominal surgery with a standardized general anesthetic technique were randomly assigned to receive one of three study medications: group 1 (control) received normal saline; group 2 received intravenous parecoxib, 20 mg; and group 3 received intravenous parecoxib, 40 mg. The initial dose of study medication was administered when the patient first requested pain medication after surgery. All patients had access to patient-controlled analgesia (PCA) with intravenous morphine, 1 or 2 mg, with a 6-min lockout period. Subsequent doses of the same study medication were administered at 12-h and 24-h intervals after the initial dose. The postoperative opioid analgesic requirement (PCA morphine usage), pain scores, pain relief scores, side effects, and need for supplemental medications (e.g., antiemetics, antipruritics, laxatives) were recorded. RESULTS: Compared with saline, intravenous parecoxib, 20 mg and 40 mg every 12 h, significantly decreased the PCA morphine usage during the first 6 h postoperatively (group 1, 25 +/- 13 mg; group 2, 16 +/- 11 mg; group 3, 17 +/- 10 mg) and at 12 h (group 1, 34 +/- 18 mg; group 2, 24 +/- 14 mg; group 3, 23 +/- 13 mg) and 24 h (group 1, 51 +/- 27 mg; group 2, 34 +/- 20 mg; group 3, 33 +/- 21 mg) after surgery. However, there were no significant differences in the patients' global evaluation of the study medications at 12 h and 24 h between those who received intravenous parecoxib (20 or 40 mg) and saline. Moreover, the postoperative pain scores and side effect profiles were similar in the three treatment groups. CONCLUSION: Intravenous parecoxib (20 or 40 mg) was effective in decreasing the PCA opioid requirement after lower abdominal surgical procedures. However, it failed to improve pain management or reduce opioid-related side effects in the early postoperative period.