BACKGROUND: This study examined the opioid-sparing effectiveness, analgesic efficacy, and tolerability of postoperative administration of the parenteral cyclooxygenase 2 selective inhibitor, parecoxib sodium, in total hip arthroplasty patients.
METHODS: This was a multicenter, multiple-dose, randomized, double-blind, placebo-controlled study to compare the opioid-sparing effects, analgesic efficacy, and tolerability of postoperative 20 and 40 mg intravenous parecoxib sodium with placebo in hip arthroplasty patients. The first dose of study medication was administered after surgery with an intravenous bolus dose of 4 mg morphine when patients first requested pain medication; remedication with the study medication occurred at 12 and 24 h. Subsequent morphine doses (1-2 mg) were administered by patient-controlled analgesia. Efficacy was assessed by total morphine used, pain relief and pain intensity, time to last dose of morphine, and Global Evaluation rating of the study medication.
RESULTS: Parecoxib sodium, 20 and 40 mg, reduced the total amount of morphine required over 36 h by 22.1% (56.5 mg morphine) and 40.5% (43.1 mg morphine), respectively, compared with placebo (72.5 mg morphine; P < 0.01). Patients receiving 20 and 40 mg parecoxib sodium experienced significantly greater maximum pain relief compared with those in the placebo group (P < 0.05). Patients who received 20 and 40 mg parecoxib sodium discontinued PCA morphine earlier than patients receiving placebo and had significantly higher Global Evaluation ratings. Parecoxib sodium, 40 mg, plus morphine demonstrated a significantly lower incidence of fever and vomiting compared with placebo plus morphine.
CONCLUSIONS: Administration of parecoxib sodium with PCA morphine resulted in significantly improved postoperative analgesic management as defined by reduction in opioid requirement, lower pain scores, reduced time on PCA morphine, and higher Global Evaluation ratings.
BACKGROUND: Forty-eight ASA I-II patients undergoing total abdominal hysterectomy (TAH) were studied in a double blind, randomized placebo controlled trial of parecoxib for postoperative analgesia.
METHODS: All patients were given propofol 2-4 mg kg(-1) i.v., a non-depolarizing muscle relaxant, morphine 10 mg i.v. and prochlorperazine 12.5 mg i.m. intraoperatively. Their lungs were ventilated with nitrous oxide and isoflurane 1-1.5% in oxygen. Morphine was self-administered for postoperative analgesia via a patient controlled analgesia (PCA) device. Patients were allocated randomly to receive either parecoxib 40 mg i.v. or normal saline on induction of anaesthesia.
RESULTS: Twelve patients did not complete the study. Of the remaining 36 patients, there was no significant difference between the treatment groups in age, weight, ASA status, duration of surgery, or intraoperative dose of morphine. However, mean (95% CI) 24 h morphine consumption of 54 (42-65) mg in the parecoxib group was significantly (P=0.04) lower than that of 72 (58-86) mg in the placebo group. Pain intensity scores on sitting up were significantly lower (P=0.02) in the parecoxib group compared with placebo. There was no significant difference between the treatment groups in pain intensity scores at rest and on deep inspiration, or in nausea, total number of vomiting episodes, median number of rescue antiemetic doses, and sedation scores.
CONCLUSIONS: Parecoxib 40 mg i.v. may be recommended in patients having TAH as it provides morphine-sparing analgesia.
BACKGROUND: This multicentre, double-blind, placebo-controlled study compared the opioid-sparing effectiveness and clinical safety of parecoxib sodium over 48 h, in 195 postoperative patients after routine total knee replacement surgery. METHODS: Elective total primary knee arthroplasty was performed under spinal anaesthesia, with a single dose of spinal bupivacaine 10-20 mg, and intraoperative sedation with midazolam 0.5-1.0 mg i.v., or propofol <6 mg kg(-1)h(-1). Patients were randomized to receive either parecoxib sodium 20 mg twice daily (bd) i.v. (n=65), parecoxib sodium 40 mg bd i.v. (n=67), or placebo (n=63) at the completion of surgery, and after 12, 24, and 36 h. Morphine (1-2 mg) was taken by patient-controlled analgesia or by bolus doses after 30 min. RESULTS: Patients receiving parecoxib sodium 20 mg bd and 40 mg bd consumed 15.6% and 27.8% less morphine at 24 h than patients taking placebo (both P<0.05). Both doses of parecoxib sodium administered with morphine provided significantly greater pain relief than morphine alone from 6 h (P<0.05). A global evaluation of study medication demonstrated a greater level of satisfaction among patients taking parecoxib sodium than those taking placebo. Parecoxib sodium administered in combination with morphine was well tolerated. However, a reduction in opioid-type side-effects was not demonstrated in the parecoxib sodium groups. CONCLUSION: Parecoxib sodium provides opioid-sparing analgesic effects in postoperative patients.
UNLABELLED: The goal of our study was to evaluate the analgesic efficacy and safety of administering rofecoxib (1 mg/kg), a cyclo-oxygenase (COX)-2 selective nonsteroidal antiinflammatory drug, before pediatric tonsillectomy. Sixty-six patients, aged 3-11 yr, scheduled to undergo tonsillectomy received either placebo or rofecoxib (1 mg/kg). There were no significant differences between the two study groups with respect to demographics and blood loss. We found that the pain scores were significantly lower in the rofecoxib group compared with the control group at 2 h (P < 0.05) and 24 h (P < 0.006). The incidence of nausea (P < 0.03) and vomiting (P < 0.004) at home was more frequent in the control group than in the rofecoxib group. We conclude that a single preoperative dose of rofecoxib resulted in less vomiting and lower 24-h pain scores in pediatric patients undergoing an elective tonsillectomy.
IMPLICATIONS: In children undergoing tonsillectomy, a single preoperative dose of rofecoxib decreases 2- and 24-h pain and decreases nausea and vomiting at home.
UNLABELLED: We designed this randomized, double-blinded, placebo-controlled study to compare the analgesic effect of the cyclooxygenase-2 inhibitors rofecoxib and celecoxib with acetaminophen when administered before outpatient otolaryngologic surgery in 240 healthy subjects. Patients were assigned to one of four study groups: Group 1, control (vitamin C 500 mg); Group 2, acetaminophen 2 g; Group 3, celecoxib 200 mg; or Group 4, rofecoxib 50 mg. The first oral dose of the study medication was administered 15-45 min before surgery, and a second dose of the same medication was given on the morning after surgery. Recovery times, side effects, pain scores, and the use of rescue analgesics were recorded. Follow-up evaluations were performed at 24 and 48 h after surgery to assess postdischarge pain, analgesic requirements, nausea, and patient satisfaction with their postoperative pain management and quality of recovery. The need for rescue analgesia and peak pain scores were used as the primary end points for estimating efficacy, and the costs to achieve complete satisfaction with analgesia were used for the cost-efficacy comparisons. Premedication with oral rofecoxib (50 mg) or celecoxib (200 mg) was more effective than placebo in reducing postoperative pain scores and analgesic requirements in the postoperative care unit and after discharge. The analgesic efficacy of oral acetaminophen (2 g) was limited to the postdischarge period. Patient satisfaction with pain management was improved in all three treatment groups compared with placebo but was higher with celecoxib and rofecoxib compared with acetaminophen. Rofecoxib was also more effective than celecoxib in reducing pain and improving patient satisfaction after otolaryngologic surgery. Rofecoxib achieved complete satisfaction with pain control in one additional patient, who would not have otherwise been satisfied, at lower incremental costs to the institution compared with celecoxib. We conclude that rofecoxib 50 mg orally is more cost-effective for reducing postoperative pain and improving patient satisfaction with their postoperative pain management than celecoxib (200 mg) or acetaminophen (2 g) in the ambulatory setting.
IMPLICATIONS: Oral premedication with rofecoxib (50 mg) was more effective than celecoxib (200 mg) and acetaminophen (2 g) in reducing postoperative pain and in improving the quality of recovery and patient satisfaction with pain management after outpatient otolaryngologic surgery with only a small increase in cost of care.
This multicenter, randomized, double-blind, placebo-controlled study evaluated the analgesic efficacy and opioid-sparing effects of valdecoxib, a potent COX-2 specific inhibitor, in patients undergoing knee replacement. Patients received morphine by patient-controlled analgesia (PCA), and valdecoxib 40 mg or 80 mg daily, or placebo, for up to two days. Efficacy was assessed by the cumulative amount of morphine administered over 48 hours, pain intensity and patient's evaluation of medication. Morphine consumption over 48 hours by patients receiving valdecoxib 40 mg or 80 mg daily plus morphine was 83.7% and 75.8% (P < 0.05) of the total amount consumed by patients receiving morphine alone. Patients receiving valdecoxib 40 mg and 80 mg daily experienced significantly lower maximum pain intensity on Day 2 (P < 0.05), and rated their study medication significantly higher than patients receiving morphine alone. Valdecoxib plus morphine was well tolerated. Thus, valdecoxib in combination with morphine provides multi-modal analgesia that reduces pain and opioid use and increases patient satisfaction following knee replacement surgery.
UNLABELLED: Recently, the Food and Drug Administration increased the celecoxib dosage recommendation from 200 mg to 400 mg for acute pain management. No studies have directly compared the analgesic efficacy of different doses of celecoxib for the prevention of postoperative pain. In this prospective, double-blinded, placebo-controlled study, we compared oral celecoxib 200 mg to 400 mg when administered for premedication of outpatients undergoing minor ear-nose-throat surgery. A total of 93 healthy outpatients were assigned to 1 of 3 study groups: control (placebo; n = 30), celecoxib 200 mg (n = 30), or celecoxib 400 mg (n = 33). The study drug was given orally 30-45 min before surgery, and all patients received a standardized general anesthetic technique. During the postoperative period, pain scores (0-10), recovery times, the need for rescue analgesics, quality of recovery (0-100), patient satisfaction with pain management (0-100), and side effects were recorded. Pain was assessed at 30-min intervals using a verbal rating scale, with 0 = no pain to 10 = worst pain imaginable, in the postanesthesia care unit and day surgery unit recovery areas and at 24 h after surgery. Celecoxib 400 mg was significantly more effective than 200 mg (and placebo) in reducing postoperative pain. Both celecoxib 200 mg and 400 mg were more effective than placebo in reducing the postoperative fentanyl requirement (74 +/- 67 micro g and 56 +/- 62 micro g versus 120 +/- 86 micro g, respectively). The larger dose of celecoxib significantly reduced the percentage of patients with severe pain at discharge (6% versus 37% and 30% in the celecoxib 200 mg and control groups, respectively). The median number of doses of oral analgesic medication after discharge was also significantly reduced in the celecoxib 400 mg group (0 versus 2 and 2 in the celecoxib 200 mg and control groups, respectively). However, no differences were found among the three study groups with respect to recovery times and secondary outcome variables (e.g., patient satisfaction and quality of recovery). We conclude that oral premedication with celecoxib 400 mg was more effective than 200 mg in reducing severe postoperative pain and the need for rescue analgesic medication in the postoperative period.
IMPLICATIONS: Oral premedication with celecoxib 400 mg was more effective than 200 mg in reducing postoperative pain and the need for rescue analgesic medication in the early postoperative period. However, neither dose of celecoxib was more effective than a placebo in facilitating the recovery process after outpatient surgery.
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.
UNLABELLED: Nonsteroidal antiinflammatory drugs (NSAIDs) provide effective postoperative analgesia after arthroscopic knee surgery. Some investigators have suggested that the preemptive administration of NSAIDs may reduce postoperative analgesic requirements and hypersensitivity. We evaluated the analgesic effect of administering rofecoxib either before or after surgical incision in patients undergoing arthroscopic knee surgery under local anesthesia. Sixty patients undergoing arthroscopic meniscectomy were randomized into three groups. All patients received intraarticular bupivacaine 0.25% pre- and postsurgery together with IV sedation using midazolam and propofol. The Preincisional group received a single 50 mg dose of rofecoxib 1 h before surgery, the Postincisional group received rofecoxib 50 mg after the completion of surgery, and the Placebo group received a placebo tablet before surgery. Pain scores, the time to first opioid use, and 24-h analgesic use were recorded. Analgesic duration, defined as the time from completion of surgery until first opioid use, was significantly longer in those patients receiving pre- (803 +/- 536 min) versus postincisional (461 +/- 344 min) rofecoxib or placebo (318 +/- 108 min). The 24 h acetaminophen/oxycodone use was less in the Preincisional group (1.5 +/- 0.6 pills) versus the Postincisional group (3.3 +/- 1.3 pills) or the Placebo group (5.5 +/- 1.6 pills). Pain scores with movement were lower in the Preincisional group at all postoperative time intervals. We conclude that rofecoxib provides effective postoperative analgesia for arthroscopic meniscectomy. Further, the administration of rofecoxib 50 mg before surgery provides a longer duration of postoperative analgesia, less 24 h opioid use, and lower incidental pain scores compared with administering the drug after the completion of surgery.
IMPLICATIONS: The administration of rofecoxib 50 mg before arthroscopic knee surgery provides a longer duration of analgesia, less 24-h opioid use, and lower pain scores than administering the drug after the completion of surgery.
UNLABELLED: In this study we evaluated the analgesic efficacy and the opioid-sparing effect of rofecoxib in ear-nose-throat surgery patients. Patients undergoing nasal septal or sinus surgery were randomized to receive either oral placebo or rofecoxib 50 mg 1 h before surgery. All patients received propofol 0.8 mg/kg, fentanyl 1 microg/kg, and local anesthesia at the operative site. Sedation was maintained by a continuous infusion of propofol adjusted to maintain sedation at a 2-3 level on the Ramsey scale. Additional fentanyl 0.5-1 microg/kg was administered at the patient's request or if the verbal rating scale score was >4. Patient sedation and pain scores were obtained at 5, 15, 30 45, and 60 min during surgery and 30 min and 2, 4, 6, 12, and 24 h after completion of the procedure. During the postoperative period, diclofenac 75 mg IM was administered for analgesia at the patient's request or if the visual analog scale (VAS) rating for pain was more than 4. VAS pain scores, intraoperative fentanyl, and postoperative diclofenac requirements were significantly smaller in the rofecoxib group compared with the placebo group (P < 0.001). The times to first analgesic request were also significantly less in the rofecoxib group. We conclude that the preoperative administration of oral rofecoxib provided a significant analgesic benefit and decreased the need for opioids in patients undergoing nasal septal and nasal sinus surgery.
IMPLICATIONS: The aim of this study was to evaluate the analgesic efficacy and opioid-sparing effect of rofecoxib, a new selective cyclooxygenase-2 inhibitor drug, in ear-nose-throat surgery patients. Preoperative administration of oral rofecoxib provided a significant analgesic benefit and decreased the need for opioids in patients undergoing nasal septal and nasal sinus surgery.
This study examined the opioid-sparing effectiveness, analgesic efficacy, and tolerability of postoperative administration of the parenteral cyclooxygenase 2 selective inhibitor, parecoxib sodium, in total hip arthroplasty patients.
METHODS:
This was a multicenter, multiple-dose, randomized, double-blind, placebo-controlled study to compare the opioid-sparing effects, analgesic efficacy, and tolerability of postoperative 20 and 40 mg intravenous parecoxib sodium with placebo in hip arthroplasty patients. The first dose of study medication was administered after surgery with an intravenous bolus dose of 4 mg morphine when patients first requested pain medication; remedication with the study medication occurred at 12 and 24 h. Subsequent morphine doses (1-2 mg) were administered by patient-controlled analgesia. Efficacy was assessed by total morphine used, pain relief and pain intensity, time to last dose of morphine, and Global Evaluation rating of the study medication.
RESULTS:
Parecoxib sodium, 20 and 40 mg, reduced the total amount of morphine required over 36 h by 22.1% (56.5 mg morphine) and 40.5% (43.1 mg morphine), respectively, compared with placebo (72.5 mg morphine; P < 0.01). Patients receiving 20 and 40 mg parecoxib sodium experienced significantly greater maximum pain relief compared with those in the placebo group (P < 0.05). Patients who received 20 and 40 mg parecoxib sodium discontinued PCA morphine earlier than patients receiving placebo and had significantly higher Global Evaluation ratings. Parecoxib sodium, 40 mg, plus morphine demonstrated a significantly lower incidence of fever and vomiting compared with placebo plus morphine.
CONCLUSIONS:
Administration of parecoxib sodium with PCA morphine resulted in significantly improved postoperative analgesic management as defined by reduction in opioid requirement, lower pain scores, reduced time on PCA morphine, and higher Global Evaluation ratings.
