Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy

BMC Anesthesiology
R Andrew MooreM Bertolotti

Abstract

Dexketoprofen trometamol plus tramadol hydrochloride is a new oral combination of two analgesics, which have different mechanisms of action for the treatment of moderate to severe acute pain. Randomised, double-blind, parallel, placebo and active-controlled, single and multiple-dose study to evaluate the analgesic efficacy and safety of dexketoprofen/tramadol 25 mg/75 mg in comparison with the single agents (dexketoprofen 25 mg and tramadol 100 mg) in moderate to severe acute pain after abdominal hysterectomy. Patients received seven consecutive doses of study drug within a 3-day period, each dose separated by an 8-hour interval. A placebo arm was included during the single-dose phase to validate the pain model. Efficacy assessments included pain intensity, pain relief, patient global evaluation and use of rescue medication. The primary endpoint was the mean sum of pain intensity differences over the first 8 h (SPID8). The efficacy analysis included 606 patients, with a mean age of 48 years (range 25-73). The study results confirmed the superiority of the combination over the single agents in terms of the primary endpoint (p <0.001). Secondary endpoints were generally supportive of the superiority of the combination for both si...Continue Reading

References

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Dec 1, 1998·Journal of Clinical Pharmacology·Mark McGurkDavid Mauleón

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Citations

May 26, 2017·The Cochrane Database of Systematic Reviews·Helen GaskellR Andrew Moore
Feb 29, 2020·Journal of Lower Genital Tract Disease·Fatma Faisal DarweeshAhmed A Metwally
Sep 23, 2016·The Cochrane Database of Systematic Reviews·Sheena DerryTudor Phillips
Jun 16, 2018·Drug and Therapeutics Bulletin
Mar 24, 2018·Current Medical Research and Opinion·Magdi Hanna, Jee Y Moon
Sep 10, 2017·British Journal of Clinical Pharmacology·Sebastián VidelaCarlos Plata-Salamán
Mar 23, 2017·Current Medical Research and Opinion·Giustino VarrassiCarmelo Scarpignato
Oct 14, 2016·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·O A Shavlovskaya
Jan 8, 2021·International Journal of Clinical Pharmacy·Alessandra BettiolFrancesco Lapi
Mar 11, 2021·Expert Opinion on Pharmacotherapy·Joseph V PergolizziGiustino Varrassi

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Methods Mentioned

BETA
hysterectomy

Clinical Trials Mentioned

NCT01904149

Software Mentioned

Interactive Voice / Web Response System ( IVRS / IWRS )

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