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      A randomized study of the efficacy and safety of parecoxib for the treatment of pain following total knee arthroplasty in Korean patients

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          Abstract

          Purpose

          Parecoxib is an injectable cyclooxygenase-2 inhibitor with proven postoperative analgesic efficacy in a variety of settings, including total knee arthroplasty (TKA). The effect of ethnicity on the efficacy of parecoxib for post-TKA pain has not been studied.

          Patients and methods

          This was a parallel-group, double-blind, randomized, placebo- controlled study of ethnically Korean patients aged ≥18 years who had unilateral TKA. Patients who reported moderate or severe pain 6 hours after the end of postoperative opioid analgesia were randomized to receive a single intravenous dose of parecoxib sodium 40 mg or placebo. Patients were evaluated for 24 hours postdose. The primary efficacy endpoints included time-specific pain intensity difference (PID), time-specific pain relief (PR), and time to rescue medication. The incidence and nature of adverse events (AEs) assessed safety.

          Results

          Of the 116 patients randomized, 58 received parecoxib and 58 placebo. Mean (SD) PID was significantly greater for parecoxib vs placebo 1 hour postdose (0.69 [0.67] vs 0.40 [0.59], respectively; p<0.05), and for each time point up to 24 hours. Similarly, mean (SD) PR was significantly greater for parecoxib vs placebo 1.5 hours postdose (1.63 [0.85] vs 1.07 [0.90], respectively; p=0.001), and for each time point up to 24 hours. The median time (hours:minutes) to rescue medication was significantly longer for parecoxib vs placebo (21:30 vs 4:08, respectively; p<0.001). Generally, fewer AEs were reported with parecoxib than placebo, and the AE profile was consistent with previous studies. These results are comparable to the findings from a similarly designed study in a Caucasian patient population.

          Conclusion

          Parecoxib 40 mg significantly improved postoperative pain vs placebo in Korean patients after TKA. The efficacy and safety of parecoxib in Korean patients is similar to that seen in Caucasian patients.

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          Most cited references 23

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          Contribution of central neuroplasticity to pathological pain: review of clinical and experimental evidence.

          Peripheral tissue damage or nerve injury often leads to pathological pain processes, such as spontaneous pain, hyperalgesia and allodynia, that persist for years or decades after all possible tissue healing has occurred. Although peripheral neural mechanisms, such as nociceptor sensitization and neuroma formation, contribute to these pathological pain processes, recent evidence indicates that changes in central neural function may also play a significant role. In this review, we examine the clinical and experimental evidence which points to a contribution of central neural plasticity to the development of pathological pain. We also assess the physiological, biochemical, cellular and molecular mechanisms that underlie plasticity induced in the central nervous system (CNS) in response to noxious peripheral stimulation. Finally, we examine theories which have been proposed to explain how injury or noxious stimulation lead to alterations in CNS function which influence subsequent pain experience.
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            • Article: not found

            Ethnic differences in pain and pain management.

            Considerable evidence demonstrates substantial ethnic disparities in the prevalence, treatment, progression and outcomes of pain-related conditions. Elucidating the mechanisms underlying these group differences is of crucial importance in reducing and eliminating disparities in the pain experience. Over recent years, accumulating evidence has identified a variety of processes, from neurophysiological factors to structural elements of the healthcare system, that may contribute to shaping individual differences in pain. For example, the experience of pain differentially activates stress-related physiological responses across various ethnic groups, members of different ethnic groups appear to use differing coping strategies in managing pain complaints, providers' treatment decisions vary as a function of patient ethnicity and pharmacies in predominantly minority neighborhoods are far less likely to stock potent analgesics. These diverse factors, and others may all play a role in facilitating elevated levels of pain-related suffering among individuals from ethnic minority backgrounds. Here, we present a brief, nonexhaustive review of the recent literature and potential physiological and sociocultural mechanisms underlying these ethnic group disparities in pain outcomes.
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              Postoperative pain control.

              The effective relief of pain is of the utmost importance to anyone treating patients undergoing surgery. Pain relief has significant physiological benefits; hence, monitoring of pain relief is increasingly becoming an important postoperative quality measure. The goal for postoperative pain management is to reduce or eliminate pain and discomfort with a minimum of side effects. Various agents (opioid vs. nonopioid), routes (oral, intravenous, neuraxial, regional) and modes (patient controlled vs. "as needed") for the treatment of postoperative pain exist. Although traditionally the mainstay of postoperative analgesia is opioid based, increasingly more evidence exists to support a multimodal approach with the intent to reduce opioid side effects (such as nausea and ileus) and improve pain scores. Enhanced recovery protocols to reduce length of stay in colorectal surgery are becoming more prevalent and include multimodal opioid sparing regimens as a critical component. Familiarity with the efficacy of available agents and routes of administration is important to tailor the postoperative regimen to the needs of the individual patient.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2018
                23 February 2018
                : 11
                : 427-433
                Affiliations
                [1 ]Pfizer Inc., New York, NY, USA
                [2 ]Pfizer Pharmaceutical Korea Ltd, Seoul, South Korea
                Author notes
                Correspondence: Margaret Noyes Essex, Pfizer Inc., 235 East 42nd Street, New York, NY, USA, Tel +1 212 733 8018, Fax +1 646 411 5967, Email margaret.essex@ 123456pfizer.com
                Article
                jpr-11-427
                10.2147/JPR.S147481
                5827681
                © 2018 Essex et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

                Anesthesiology & Pain management

                total knee arthroplasty, parecoxib, cox-2 inhibitor

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