Tramadol hydrochloride/acetaminophen combination versus non-steroidal anti-inflammatory drug for the treatment of perioperative pain after total knee arthroplasty: A prospective, randomized, open-label clinical trial

While many of the commonly used treatments for perioperative pain after total knee arthroplasty (TKA) have been recognized as effective, there is still insufficient evidence for oral medication. In orthopedics, non-steroidal anti-inflammatory drugs (NSAIDs) have been commonly used for perioperative...

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Veröffentlicht in:Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association 2016-09, Vol.21 (5), p.625-629
Hauptverfasser: Mochizuki, Takeshi, Yano, Koichiro, Ikari, Katsunori, Hiroshima, Ryo, Takaoka, Hiromitsu, Kawakami, Kosei, Koenuma, Naoko, Ishibashi, Mina, Shirahata, Toshikatsu, Momohara, Shigeki
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container_title Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association
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creator Mochizuki, Takeshi
Yano, Koichiro
Ikari, Katsunori
Hiroshima, Ryo
Takaoka, Hiromitsu
Kawakami, Kosei
Koenuma, Naoko
Ishibashi, Mina
Shirahata, Toshikatsu
Momohara, Shigeki
description While many of the commonly used treatments for perioperative pain after total knee arthroplasty (TKA) have been recognized as effective, there is still insufficient evidence for oral medication. In orthopedics, non-steroidal anti-inflammatory drugs (NSAIDs) have been commonly used for perioperative pain; however, serious adverse events have been reported. Conversely, tramadol hydrochloride/acetaminophen combination (TRAM/APAP) therapy has been shown to reduce pain, particularly for chronic pain in Japan. This study aimed to determine TRAM/APAP efficacy in comparison with NSAIDs for perioperative pain after TKA. Two hundred eighty patients were enrolled in this study; 137 patients were treated with TRAM/APAP, and 143 patients were treated with NSAID from postoperative (PO) day 2. The primary endpoint was a comparison between the pain visual analog scale (VAS) change from baseline (PO day 2) and PO day 4, day 7, day 10, and day 14. The second endpoint was the number of days until the patient achieved independence from cane walking. Analysis of endpoints included 130 and 139 patients in the TRAM/APAP and NSAID groups, respectively. The pain VAS change in the TRAM/APAP group on any of the measurement days was significantly improved compared with the NSAID group (P 
doi_str_mv 10.1016/j.jos.2016.07.011
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In orthopedics, non-steroidal anti-inflammatory drugs (NSAIDs) have been commonly used for perioperative pain; however, serious adverse events have been reported. Conversely, tramadol hydrochloride/acetaminophen combination (TRAM/APAP) therapy has been shown to reduce pain, particularly for chronic pain in Japan. This study aimed to determine TRAM/APAP efficacy in comparison with NSAIDs for perioperative pain after TKA. Two hundred eighty patients were enrolled in this study; 137 patients were treated with TRAM/APAP, and 143 patients were treated with NSAID from postoperative (PO) day 2. The primary endpoint was a comparison between the pain visual analog scale (VAS) change from baseline (PO day 2) and PO day 4, day 7, day 10, and day 14. The second endpoint was the number of days until the patient achieved independence from cane walking. Analysis of endpoints included 130 and 139 patients in the TRAM/APAP and NSAID groups, respectively. The pain VAS change in the TRAM/APAP group on any of the measurement days was significantly improved compared with the NSAID group (P &lt; 0.01). Similarly, the TRAM/APAP group achieved cane-walking independence significantly faster than the NSAID group (P &lt; 0.01). Efficacy for perioperative pain management after TKA of TRAM/APAP was shown to be superior to that of NSAID; TRAM/APAP was also effective in improving the progress of rehabilitation.</description><identifier>ISSN: 0949-2658</identifier><identifier>EISSN: 1436-2023</identifier><identifier>DOI: 10.1016/j.jos.2016.07.011</identifier><identifier>PMID: 27531573</identifier><language>eng</language><publisher>Japan: Elsevier B.V</publisher><subject>Acetaminophen - administration &amp; dosage ; Aged ; Aged, 80 and over ; Anti-Inflammatory Agents, Non-Steroidal - administration &amp; dosage ; Arthroplasty, Replacement, Knee - adverse effects ; Arthroplasty, Replacement, Knee - methods ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug Combinations ; Female ; Humans ; Male ; Osteoarthritis, Knee - surgery ; Pain Measurement ; Pain, Postoperative - diagnosis ; Pain, Postoperative - drug therapy ; Patient Satisfaction - statistics &amp; numerical data ; Prospective Studies ; Severity of Illness Index ; Statistics, Nonparametric ; Tramadol - administration &amp; dosage ; Treatment Outcome</subject><ispartof>Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association, 2016-09, Vol.21 (5), p.625-629</ispartof><rights>2016 The Japanese Orthopaedic Association</rights><rights>Copyright © 2016 The Japanese Orthopaedic Association. 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Yano, Koichiro ; Ikari, Katsunori ; Hiroshima, Ryo ; Takaoka, Hiromitsu ; Kawakami, Kosei ; Koenuma, Naoko ; Ishibashi, Mina ; Shirahata, Toshikatsu ; Momohara, Shigeki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c469t-ed9e91fed7c6dc52feca8c077931a3768c45e63c86c8a903191c53db9684cf593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Acetaminophen - administration &amp; dosage</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - administration &amp; dosage</topic><topic>Arthroplasty, Replacement, Knee - adverse effects</topic><topic>Arthroplasty, Replacement, Knee - methods</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Osteoarthritis, Knee - surgery</topic><topic>Pain Measurement</topic><topic>Pain, Postoperative - diagnosis</topic><topic>Pain, Postoperative - drug therapy</topic><topic>Patient Satisfaction - statistics &amp; 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In orthopedics, non-steroidal anti-inflammatory drugs (NSAIDs) have been commonly used for perioperative pain; however, serious adverse events have been reported. Conversely, tramadol hydrochloride/acetaminophen combination (TRAM/APAP) therapy has been shown to reduce pain, particularly for chronic pain in Japan. This study aimed to determine TRAM/APAP efficacy in comparison with NSAIDs for perioperative pain after TKA. Two hundred eighty patients were enrolled in this study; 137 patients were treated with TRAM/APAP, and 143 patients were treated with NSAID from postoperative (PO) day 2. The primary endpoint was a comparison between the pain visual analog scale (VAS) change from baseline (PO day 2) and PO day 4, day 7, day 10, and day 14. The second endpoint was the number of days until the patient achieved independence from cane walking. Analysis of endpoints included 130 and 139 patients in the TRAM/APAP and NSAID groups, respectively. The pain VAS change in the TRAM/APAP group on any of the measurement days was significantly improved compared with the NSAID group (P &lt; 0.01). Similarly, the TRAM/APAP group achieved cane-walking independence significantly faster than the NSAID group (P &lt; 0.01). Efficacy for perioperative pain management after TKA of TRAM/APAP was shown to be superior to that of NSAID; TRAM/APAP was also effective in improving the progress of rehabilitation.</abstract><cop>Japan</cop><pub>Elsevier B.V</pub><pmid>27531573</pmid><doi>10.1016/j.jos.2016.07.011</doi><tpages>5</tpages></addata></record>
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subjects Acetaminophen - administration & dosage
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
Arthroplasty, Replacement, Knee - adverse effects
Arthroplasty, Replacement, Knee - methods
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Combinations
Female
Humans
Male
Osteoarthritis, Knee - surgery
Pain Measurement
Pain, Postoperative - diagnosis
Pain, Postoperative - drug therapy
Patient Satisfaction - statistics & numerical data
Prospective Studies
Severity of Illness Index
Statistics, Nonparametric
Tramadol - administration & dosage
Treatment Outcome
title Tramadol hydrochloride/acetaminophen combination versus non-steroidal anti-inflammatory drug for the treatment of perioperative pain after total knee arthroplasty: A prospective, randomized, open-label clinical trial
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