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

Autor:	McQuay HJ; Balliol College, University of Oxford, Oxford, UK henrymcquay@gmail.com., Moore RA; Pain Research & Nuffield Division of Anaesthetics, University of Oxford, The Churchill, Oxford OX1 3BJ, UK., Berta A; Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary., Gainutdinovs O; Department of Joint Surgery, Hospital of Traumatology and Orthopaedics, Riga, Latvia., Fülesdi B; Department of Anesthesiology and Intensive Care, University of Debrecen, Debrecen, Hungary., Porvaneckas N; Department of Traumatology and Orthopaedics, Republican Vilnius University Hospital, Vilnius, Lithuania., Petronis S; Department of Traumatology and Orthopaedics, Riga's 2nd Hospital, Riga, Latvia., Mitkovic M; Clinic for Orthopaedics and Traumatology, Clinical Center Nis, University of Nis, Nis, Serbia., Bucsi L; Department of Orthopaedics, St George University Teaching Hospital, Szekesfehervar, Hungary., Samson L; Department of Orthopaedics, MÁV Hospital, Szolnok, Hungary., Zegunis V; Department of Traumatology, Klaipeda University Hospital, Klaipeda, Lithuania., Ankin ML; Orthopedic & Trauma Center, Kiev Regional Clinical Hospital, Kiev, Ukraine., Bertolotti M; Clinical Research, Menarini Ricerche S.p.A. - Menarini Group, Florence, Italy., Pizà-Vallespir B; Clinical Research, Laboratorios Menarini S.A. - Menarini Group, Badalona, Spain., Cuadripani S; Clinical Research, Laboratorios Menarini S.A. - Menarini Group, Badalona, Spain., Contini MP; Clinical Research, Menarini Ricerche S.p.A. - Menarini Group, Florence, Italy., Nizzardo A; Clinical Research, Menarini Ricerche S.p.A. - Menarini Group, Florence, Italy.
Jazyk:	angličtina
Zdroj:	British journal of anaesthesia [Br J Anaesth] 2016 Feb; Vol. 116 (2), pp. 269-76.
DOI:	10.1093/bja/aev457
Abstrakt:	Background: 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. Methods: 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). Results: 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 components were superior to placebo (P<0.05), confirming model sensitivity. Most secondary analyses supported the superiority of the combination. The incidence of adverse drug reactions was low and similar among active treatment groups. Conclusion: The efficacy results confirmed the superiority of dexketoprofen/tramadol over its single components, even at higher doses (tramadol), with a safety profile fully in line with that previously known for these agents in monotherapy. Clinical Trial Registration: EudraCT 2012-004548-31 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004548-31);ClinicalTrials.gov NCT01902134 (https://www.clinicaltrials.gov/ct2/show/NCT01902134?term=NCT01902134&rank=1). (© The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia.)
Databáze:	MEDLINE
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