Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty

British Journal of Anaesthesia
H J McQuayA Nizzardo

Abstract

The aim was to evaluate the analgesic efficacy and safety of the dexketoprofen/tramadol 25 mg/75 mg fixed-dose combination vs dexketoprofen (25 mg) and tramadol (100 mg) in moderate-to-severe acute pain after total hip arthroplasty. This was a randomized, double-blind, parallel-group study in patients experiencing pain of at least moderate intensity on the day after surgery, compared with placebo at first administration to validate the pain model. The study drug was administered orally every 8 h throughout a 5 day period. Rescue medication, metamizole 500 mg, was available during the treatment period. The evaluation of efficacy was based on patient assessments of pain intensity and pain relief. The primary end point was the mean sum of the pain intensity difference values throughout the first 8 h (SPID8). Overall, 641 patients, mean age 62 (range 29-80) yr, were analysed; mean (sd) values of SPID8 were 247 (157) for dexketoprofen/tramadol, 209 (155) for dexketoprofen, 205 (146) for tramadol, and 151 (159) for placebo. The primary analysis confirmed the superiority of the combination over dexketoprofen 25 mg (P=0.019; 95% confidence interval 6.4-73) and tramadol 100 mg (P=0.012; 95% confidence interval 9.5-76). The single compon...Continue Reading

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Citations

Mar 23, 2017·Current Medical Research and Opinion·Giustino VarrassiCarmelo Scarpignato
Mar 24, 2018·Current Medical Research and Opinion·Magdi Hanna, Jee Y Moon
Sep 23, 2016·The Cochrane Database of Systematic Reviews·Sheena DerryTudor Phillips
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Jul 8, 2021·The Journal of Bone and Joint Surgery. American Volume·Joseph A KaramJavad Parvizi

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