A double-blind, randomized comparison of intramuscularly and intravenously administered parecoxib sodium versus ketorolac and placebo in a post-oral surgery pain model. Single doses of parecoxib sodium intravenously are as effective as ketorolac in reducing pain after oral surgery. The analgesic efficacy of intramuscular parecoxib sodium in postoperative dental pain. Efficacy and safety of intravenous parecoxib sodium in relieving acute postoperative pain following gynecologic laparotomy surgery. A clinical trial demonstrates the analgesic activity of intravenous parecoxib sodium compared with ketorolac or morphine after gynecologic surgery with laparotomy. Single dose parecoxib significantly improves ventilatory function in early extubation coronary artery bypass surgery: a prospective randomized double blind placebo controlled trial. Intravenous parecoxib sodium foracute pain after orthopedic knee surgery.
Parecoxib sodium is an injectable cyclooxygenase-2-specific inhibitor developed for the treatment of acute pain. The analgesic efficacy of IV and IM parecoxib has been demonstrated in previous pilot studies using the post-oral surgery pain model.
                This study was conducted to characterize the analgesic efficacy of parecoxib in healthy adults after oral surgery while comparing the efficacy and tolerability of the IV and IM routes of administration.
                This was a double-blind, randomized, parallel-group, placebo- and active-controlled, single-dose, single-center trial. Patients experiencing moderate to severe post-operative pain after the extraction of > or =2 impacted third molars were randomized to receive parecoxib sodium 20 mg IM, 20 mg IV, 40 mg IM, or 40 mg IV; ketorolac tromethamine 60 mg IM; or placebo. Patients assessed pain intensity and pain relief (PR) at baseline and at designated intervals for 24 hours after administration of study medication or until rescue medication was taken. Analgesic efficacy was assessed in terms of time-specific pain intensity difference (PID) and PR, time to onset of analgesia, and time to use of rescue medication.
                Three hundred four patients were randomized to treatment. Parecoxib sodium 20 and 40 mg IM or IV and ketorolac 60 mg IM were significantly superior to placebo in PID, PR, time to onset of analgesia, and time to use of rescue medication (P < or = 0.05). Equal IV and IM doses of parecoxib were comparable on these measures; however, time to use of rescue medication was longer with IM compared with IV administration. Both doses of parecoxib were comparable to ketorolac 60 mg IM in time to onset of analgesia, but parecoxib 40 mg had a significantly longer duration of action (P < or = 0.05). The few statistically significant differences in PID and PR between parecoxib 40 mg and ketorolac favored ketorolac versus parecoxib 40 mg IV at earlier time points and parecoxib 40 mg IM versus ketorolac at later time points (P < or = 0.05). All treatments were well tolerated.
                Parecoxib IV and IM provided effective analgesia. The 40-mg dose was comparable to ketorolac 60 mg on most measures of analgesia but had a longer duration of action. 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.
                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.
                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.
                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. 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.
                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.
                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.
                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.
                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. This study tested the hypothesis that an injectable cyclooxygenase (COX)-2-specific inhibitor will be at least as effective and well tolerated as a COX-nonspecific conventional nonsteroidal antiinflammatory drug (NSAID) by comparing the analgesic efficacy and tolerability of one intravenous dose of parecoxib sodium, an injectable prodrug of the novel COX-2-specific inhibitor, valdecoxib, with ketorolac and placebo in postoperative laparotomy surgery patients. Intravenous morphine, 4 mg, was studied as a positive analgesic control.
                In this multicenter, double-blinded, placebo-controlled study, women experiencing moderate-to-severe pain on the first day after abdominal hysterectomy or myomectomy received one intravenous dose of parecoxib sodium, 20 or 40 mg, ketorolac, 30 mg, morphine, 4 mg, or placebo. Analgesic efficacy and tolerability were evaluated for 24 h postdose or until patients, whose pain was not adequately controlled, opted to receive rescue analgesia.
                Two hundred two patients were enrolled. All treatment groups had comparable demographics and baseline pain status. All active treatments had an equally rapid time to onset of analgesia (10-23 min). Overall, each parecoxib sodium dose and ketorolac were significantly superior to morphine and placebo for most measures of analgesic efficacy at most time points, including a significantly longer (two- to threefold) time to rescue analgesia (P </= 0.05). All treatments were well tolerated.
                Single intravenous doses of parecoxib sodium, 20 mg and 40 mg, have comparable analgesic effects and are well tolerated after laparotomy surgery. Parecoxib sodium appears to be as effective as intravenous ketorolac, 30 mg, and superior to intravenous morphine, 4 mg. The purpose of this study was to compare the analgesic activity of 2 doses of parecoxib sodium, ketorolac, and morphine with placebo after gynecologic surgery that requires laparotomy.
                In a randomized, controlled, double-blind, parallel-group study, 208 patients, after surgical hysterectomy, received single-dose intravenous placebo, parecoxib sodium 20 mg or 40 mg, ketorolac 30 mg, or morphine 4 mg followed by multiple-dose parecoxib sodium or ketorolac as needed. Primary efficacy variables were time to onset of analgesia, pain intensity differences, pain relief, time to first rescue/remedication, and global evaluation of study medication.
                Single-dose parecoxib sodium 40 mg provided significantly better pain responses to placebo or morphine 4 mg and was comparable to ketorolac 30 mg. Multiple-dose parecoxib sodium 20 mg, 4 times daily, or 40 mg, twice daily, was comparable to ketorolac 30 mg, 4 times daily. Parecoxib sodium was well tolerated.
                Parecoxib sodium is an effective analgesic in the management of acute postoperative pain after laparotomy surgery. Parecoxib, a cyclo oxygenase-2 inhibiting non-steroidal anti-inflammatory drug, has been widely used for postoperative analgesia. Our aim was to quantify the benefit of a single dose after coronary artery bypass grafting.
                The investigation was carried out as a randomized double blind placebo controlled study. A single i.v. dose of parecoxib 40 mg or placebo was given at closure of sternotomy. No opioid other than morphine was given in the first 24 postoperative hours. Pain was assessed using both a Visual Analogue Score (1-10), and the amount of morphine used via a morphine patient controlled analgesia pump. Creatinine clearance was measured before and after operation from 24 h urine collections. After a global announcement by Pfizer that paracoxib was 'contraindicated in patients with ischaemic heart disease' further recruitment was suspended and the collected data from 40 patients were analysed.
                Twenty-one patients received parecoxib and 19 received placebo. Amongst those who received parecoxib, there was a highly significant sparing of rescue medication before tracheal extubation (P=0.004) compared with placebo, and an overall 35% morphine sparing effect during the first 6 h post extubation after correction for the variability in extubation time (P=0.037). Respiration, as measured by arterial carbon dioxide tension at the time of extubation, was significantly better in the parecoxib group (P=0.045). Significantly more furosemide was given for postoperative oliguria in those patients who received parecoxib (P=0.036). After correcting for differences in diuretic usage and fluid balance, parecoxib was associated with a significant increase in plasma creatinine (P=0.041).
                A single dose of parecoxib has a significant opioid sparing effect in the first 6 h after coronary artery bypass grafting which resulted in significantly improved ventilation with mild elevation of plasma creatinine within normal limits. Our objective in a randomized, multicenter, double-blind, parallel-group, placebo- and active-controlled study was to evaluate and compare the analgesic effectiveness of single intravenous (IV) doses of parecoxib sodium 20 and 40 mg, morphine 4 mg, and ketorolac 30 mg in the postsurgical orthopedic pain model. After undergoing unilateral total knee replacement surgery, 208 healthy adult patients were randomized to receive placebo or a study drug within 6 hours of discontinuation of patient-controlled analgesia on postoperative day 1. Onset of analgesia was similarly rapid with IV parecoxib sodium 40 mg, morphine, and ketorolac. Level and duration of analgesia were significantly superior with parecoxib sodium than with morphine and were similar for parecoxib sodium and ketorolac. Parecoxib sodium was safe and well tolerated. In conclusion, IV parecoxib sodium 40 mg is as effective as ketorolac 30 mg and is more effective than morphine 4 mg and therefore has potential widespread utility in acute postoperative pain management.
A single dose of parecoxib 20 mg or 40 mg provided effective analgesia for 50 to 60% of those treated compared to about 15% with placebo, and was well tolerated. Duration of analgesia was longer, and significantly fewer participants required rescue medication over 24 hours with the higher dose.