A Study on the Assessment of Safety and Efficacy of Intramuscular Parecoxib in Adult Patients for Postoperative Analgesia (original) (raw)
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Intravenous parecoxib for acute postoperative pain in adults
Cochrane Database of Systematic Reviews, 2008
This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the efficacy and adverse effects of single dose parecoxib in studies of acute postoperative pain using methods that permit comparison with other analgesics evaluated in standardised trials using almost identical methods and outcomes. BACKGROUND In the clinical development of analgesics, the first step is to demonstrate that they take away pain. This can only be done by testing them in people with established moderate or severe pain, and experience has shown that this must be clinical, rather than experimentallyinduced, pain. To show that the analgesic is working it is necessary to use placebo (McQuay 2005). There are clear ethical considerations in doing this. These ethical considerations are answered by using acute pain situations where the pain is expected to go away, and by providing additional analgesia, also called rescue analgesia, if the pain has not diminished after about an hour. This is fair, because not all participants given an analgesic will have significant pain relief, and about 18% of participants given placebo will have significant pain relief (Moore 2006). The demonstration that a drug is an analgesic after a single dose in an acute pain situation is important. In itself, such demonstration does not determine the utility of the tested drug in any particular situation. However, because drugs that work well in one pain condition generally work well in others, with a similar relative efficacy, acute pain trials provide useful information relevant to many other pain conditions. Knowing the relative efficacy of
Journal of pain research, 2017
Nonselective, nonsteroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 (COX-2) inhibitors are associated with safety issues including cardiovascular, renal, and gastrointestinal (GI) events. To examine the safety of parecoxib, a COX-2 inhibitor, for the management of postoperative pain. Pooled analysis of 28 placebo-controlled trials of parecoxib and review of postauthorization safety data. Prespecified safety events commonly associated with COX-2 inhibitors and/or NSAIDs. In the clinical trial analysis, the frequency of each event was compared between treatment groups using a chi-square test. In the postauthorization review, the number of confirmed cases, along with outcome, was presented for each event. In the clinical trial analysis, GI-related events occurred in ~0.2% of patients in the parecoxib and placebo groups. Renal failure and impairment was similar between parecoxib (1.0%) and placebo (0.9%). The occurrence of arterial (parecoxib=0.3%; placebo=0.2%) a...
Asian Spine Journal, 2018
Prospective randomized, double-blind controlled trial. Purpose: Here, we aim to compare the efficacy and safety of pain control between pre-and postoperative parecoxib administration in patients who have undergone major spine surgery. Overview of Literature: Several studies have compared the efficacy of pre-and postoperative administration of parecoxib, which led to inconclusive results owing to variation in operative time. Preincisional parecoxib administration reduces inflammatory response in major spine surgery requiring longer operative time; however, it may not reduce pain as much as parecoxib administration immediately after surgery would. Methods: Totally, 127 patients who underwent major spine surgery were randomly divided into three groups: pre-group, which received 40 mg parecoxib before skin incision and at 12 and 24 hours after the first dose; post-group, which received the same dose at wound closure and at 12 and 24 hours after the first dose; and control group, which did not receive any parecoxib. Efficacy and safety of parecoxib were measured based on pain score, morphine consumption, and side effects from both morphine and parecoxib at 24 hours after surgery. Results: Initial postoperative pain score, postoperative pain score at rest, and accumulative morphine consumption at 24 hours after surgery were similar between the pre-and post-groups. Despite the significantly lower pain score and morphine consumption in both pre-and post-groups compared with the control group, cumulative morphine consumption at 24 hours after surgery was reduced by approximately 50% in the pre-group and 46% in the post-group compared. Analgesic-related complication incidence was similar in all groups. Conclusions: The timing of parecoxib administration, either before or after major spinal surgery, did not affect the safety and analgesic efficacy of pain management.
Effect of Parecoxib on Postoperative Pain After Lumbar Spine Surgery
Spine, 2008
Study Design. A bicenter randomized, patients, healthcare providers, and data collectors blind placebo-controlled trial in multimodal analgesia for postoperative lumbar spine surgery was conducted. Objective. To assess the efficacy and safety of parecoxib on postoperative pain management after posterior lumbar spine surgery. Summary of Background Data. Systematic reviews suggest that cyclo-oxygenase-2 inhibitors are an effective treatment for acute postoperative pain. However, previous trials on lumbar spine surgery showed equivocal efficacy of cyclo-oxygenase-2 inhibitors for postoperative pain relief. Methods. In this study, 120 patients undergoing posterior lumbar discectomy, spinal decompression, or spinal fusion were stratified based on the surgical procedure to 3 groups (n ϭ 40) and randomly allocated to receive multidoses of parecoxib 40 mg/dose or placebo. Efficacy was assessed by total morphine used from patient-controlled analgesic pump, pain intensity, pain relief, and the patient's subjective rating of the medication. Results. Parecoxib 40 mg reduced the total amount of morphine required over 48 hours by 39% relative morphine reduction compared with placebo (P ϭ 0.0001). Pain at rest was reduced by 30% (P ϭ 0.0001). Ninety percent of patients given parecoxib experienced at least 50% maximum total pain relief compared with 58% treated with placebo. The number-needed-to-treat for 1 patient to have at least half pain relief was 3.1 (2.0-4.6). Patients' subjective rating of the medication was described as "excellent, good, and fair" by 48%, 43%, and 8% in the parecoxib group, respectively, compared with 21%, 50%, and 28% of placebo patients (P ϭ 0.004). Overall adverse effects of patients receiving parecoxib and morphine were comparable to those receiving morphine alone. Conclusion. The present study demonstrates that the perioperative administration of parecoxib with patientcontrolled analgesic morphine after lumber spine surgery resulted in significantly improved postoperative analgesic management as defined by reduction in opioid requirement, lower pain scores, and higher patients' subjective rating of the medication.
Pain and Therapy, 2017
Introduction: Orthopedic surgeries are among the most common and most painful surgeries performed. A multimodal analgesic approach is recommended to reduce opioid consumption, provide effective pain relief, and improve outcomes following surgery. This study examined the efficacy and opioid-sparing effects of parecoxib following major orthopedic surgery. Methods: This subset analysis of a large, multicenter, randomized, double-blind, placebo-controlled study of parecoxib examined treatment effects on postoperative pain severity, pain interference with function, opioid consumption, occurrence of opioid-related symptoms, safety, and patient satisfaction following major orthopedic surgery. Results: Pain scores were significantly lower in the parecoxib group (n = 142) compared with placebo (n = 139) on day 2 (-22%; p\0.001) and day 3 (-17%; p = 0.004). Pain interference with function scores were also significantly lower in the parecoxib group on day 2 (-32%; p\0.001) and day 3 (-27%; p = 0.003) relative to placebo. Additionally, significantly less supplemental morphine was required in the parecoxib group relative to placebo through 24 h (-28%; p = 0.008) and 48 h (-33%; p\0.001). Patients in the parecoxib group had a reduced risk of experiencing opioid-related symptoms including fatigue, drowsiness, inability to concentrate, confusion, nausea, constipation, and confusion on day 2 and/or day 3. Finally, more patients receiving parecoxib (42%) rated treatment as ''excellent'' compared to those receiving placebo (21%). Conclusions: These findings support the use of parecoxib for the management of pain following major orthopedic surgery.
Timing of intraoperative parecoxib analgesia in colorectal surgery
Acute Pain, 2008
Objective: The aim of this study was to determine the analgesic effect of parecoxib when administered either before or at the end of surgery in patients undergoing colorectal laparotomy. Methods: Sixty patients were randomised to three groups of 20. The PS group received intravenous parecoxib 40 mg before skin incision and normal saline at skin closure. The SP group received saline before skin incision and intravenous parecoxib 40 mg at skin closure. A control group (SS) received saline at both time points. Results: In both SP and PS groups, morphine consumption was smaller. There was a 40-55% reduction in cumulative morphine consumption in both treatment groups at all time points up to 48 h after anaesthesia finished. The greatest reduction was from 12 h to 24 h which showed a 66% reduction for the SP group and a 55% reduction for the PS group compared to control (p = 0.0003 and 0.0049, respectively, with an adjusted significance value = 0.0167). For SP and PS groups, the time to first post-operative analgesic request tended to be longer and the number of patients requesting morphine in the recovery room was less. Conclusion: Parecoxib administration at the end of surgery is as effective as at the beginning with regard to analgesic and opioid-sparing effects.
Anesthesiology, 2002
BACKGROUND: There is still controversy regarding the optimal strategy for managing postoperative nausea and vomiting (PONV) in high-risk surgical populations. Although acustimulation at the P6 acupoint has been demonstrated to be effective in preventing PONV, the effect of this nonpharmacologic therapy on the patient's recovery with respect to resumption of normal activities of daily living has not been previously assessed when it is used as part of a multimodal antiemetic regimen. Therefore, we designed this randomized, sham-controlled, and double-blind study to assess the efficacy of a disposable acupressure device (Pressure Rightா; Pressure Point Inc., Grand Rapids, MI) on the incidence of emetic episodes and quality of recovery when used in combination with ondansetron and dexamethasone for antiemetic prophylaxis. METHODS: One hundred ASA physical status I and II patients undergoing major laparoscopic procedures were randomly assigned to either a control group (n ϭ 50) receiving a "sham" acustimulation device or an acupressure group (n ϭ 50) receiving a disposable Pressure Right device placed bilaterally at the P6 point 30 to 60 minutes before induction of anesthesia. All patients received a standardized general anesthetic. A combination of ondansetron, 4 mg IV, and dexamethasone, 4 mg IV, was administered during surgery for antiemetic prophylaxis in both study groups. The incidence of nausea and vomiting and the need for "rescue" antiemetic therapy were assessed at specific time intervals for up to 72 hours after surgery. The recovery profiles and quality of recovery questionnaires were evaluated at 48 hours and 72 hours after surgery. Patient satisfaction with the management of their PONV was assessed at the end of the 72-hour study period. RESULTS: The 2 study groups did not differ in their demographic characteristics or risk factors for PONV. The incidence of vomiting at 24 hours was significantly decreased in the acupressure group (10% vs 26%, P ϭ 0.04, 95% confidence interval for absolute risk reduction 1%-31%). The overall incidence of vomiting from 0 to 72 hours after surgery was also significantly decreased from 30% to 12% in the acupressure group (P ϭ 0.03, 95% confidence interval 2%-33%).
American Journal of Obstetrics and Gynecology, 2004
Objective: 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. Study design: 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. Results: 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. Conclusion: Parecoxib sodium is an effective analgesic in the management of acute postoperative pain after laparotomy surgery. Ó 2004 Elsevier Inc. All rights reserved.
Anesthesia and Analgesia, 2001
Preoperative administration of analgesics may prevent or reduce hyperalgesia and inhibit inflammation and pain by reducing the synthesis of prostaglandins in response to surgical injury. We evaluated in this placebo-controlled study the analgesic efficacy and safety of single doses of parecoxib sodium (20, 40, and 80 mg IV) when administered before oral surgery. Efficacy assessments were recorded during the 24-h period after completion of surgery. All doses of parecoxib sodium were consistently and significantly superior to placebo as measured by time to rescue medication, proportion of patients requiring rescue medication, patient's global assessment, and pain intensity. There were no significant differences between the Parecoxib Sodium 40-and 80-mg groups, suggesting that the analgesic effect of preoperatively administered parecoxib sodium reaches a plateau at 40 mg in this model. Forty-eight percent of the Parecoxib Sodium 40-mg group required rescue medication in the 24-h study period, compared with 93% of patients in the Placebo group. Overall, there were fewer adverse events in parecoxib sodiumtreated patients compared with placebo. These findings suggest that preoperative administration of parecoxib sodium, the injectable prodrug of the cyclooxygenase-2 specific inhibitor valdecoxib, is effective, safe, and well tolerated for treating postoperative pain.