PURPOSE: Our goal was to compare the analgesic efficacy and safety of single doses of intravenous parecoxib sodium, a prodrug of the novel cyclooxygenase (COX)-2-selective inhibitor valdecoxib, with intravenous ketorolac and placebo in postoperative oral surgery patients. PATIENTS AND METHODS: Eligible patients experiencing moderate to severe pain within 6 hours of surgery to extract 2 or more impacted third molars were randomized to receive a single dose of parecoxib sodium 1, 2, 5, 10, 20, 50, or 100 mg; ketorolac 30 mg; or placebo. Analgesic efficacy was assessed over a 24-hour treatment period or until rescue analgesia was required. RESULTS:Parecoxib sodium doses (particularly 50 and 100 mg) had a rapid onset of analgesia (within 11 minutes). The analgesic efficacy of parecoxib sodium 20 to 100 mg was similar to that of ketorolac 30 mg. Parecoxib sodium doses below 20 mg had suboptimal analgesic activity compared with placebo and ketorolac. A plateau of efficacy was observed at the parecoxib sodium 50-mg dose. Parecoxib sodium 50 and 100 mg had a significantly longer duration of analgesia than ketorolac 30 mg. All doses of parecoxib sodium were well tolerated. CONCLUSIONS:Parecoxib sodium, a novel parenteral prodrug of the COX-2-selective inhibitor valdecoxib, is as effective and longer acting at 50- and 100-mg intravenous doses than a standard dose of ketorolac 30 mg intravenously. Parecoxib sodium appears to be safe and well tolerated and, therefore, merits further evaluation in other models of postsurgical pain.
RCT Entities:
PURPOSE: Our goal was to compare the analgesic efficacy and safety of single doses of intravenous parecoxib sodium, a prodrug of the novel cyclooxygenase (COX)-2-selective inhibitor valdecoxib, with intravenous ketorolac and placebo in postoperative oral surgery patients. PATIENTS AND METHODS: Eligible patients experiencing moderate to severe pain within 6 hours of surgery to extract 2 or more impacted third molars were randomized to receive a single dose of parecoxib sodium 1, 2, 5, 10, 20, 50, or 100 mg; ketorolac 30 mg; or placebo. Analgesic efficacy was assessed over a 24-hour treatment period or until rescue analgesia was required. RESULTS:Parecoxib sodium doses (particularly 50 and 100 mg) had a rapid onset of analgesia (within 11 minutes). The analgesic efficacy of parecoxib sodium 20 to 100 mg was similar to that of ketorolac 30 mg. Parecoxib sodium doses below 20 mg had suboptimal analgesic activity compared with placebo and ketorolac. A plateau of efficacy was observed at the parecoxib sodium 50-mg dose. Parecoxib sodium 50 and 100 mg had a significantly longer duration of analgesia than ketorolac 30 mg. All doses of parecoxib sodium were well tolerated. CONCLUSIONS:Parecoxib sodium, a novel parenteral prodrug of the COX-2-selective inhibitor valdecoxib, is as effective and longer acting at 50- and 100-mg intravenous doses than a standard dose of ketorolac 30 mg intravenously. Parecoxib sodium appears to be safe and well tolerated and, therefore, merits further evaluation in other models of postsurgical pain.