Dexketoprofen-tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute painReportar como inadecuado




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The Journal of Headache and Pain

, 16:60

First Online: 27 June 2015Received: 29 April 2015Accepted: 12 June 2015

Abstract

BackgroundCombination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective.

MethodsThis was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen trometamol 12.5 mg and 25 mg and tramadol hydrochloride 37.5 mg and 75 mg, given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo. The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours.

Results606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders 72 % was achieved in the dexketoprofen trometamol 25 mg plus tramadol hydrochloride 75 mg group NNT 1.6, 95 % confidence interval 1.3 to 2.1. Addition of tramadol to dexketoprofen resulted in greater peak pain relief and greater pain relief over the longer term, particularly at times longer than six hours median duration of 8.1 h. Adverse events were unremarkable.

ConclusionsDexketoprofen trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain. The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae.

Trial registrationEudraCT 2010-022798-32; Clinicaltrials.gov NCT01307020.

KeywordsDexketoprofen Tramadol Combination analgesics Postoperative pain Third molar Randomised controlled trial Dose range Electronic supplementary materialThe online version of this article doi:10.1186-s10194-015-0541-5 contains supplementary material, which is available to authorized users.

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Autor: R. Andrew Moore - C. Gay-Escoda - R. Figueiredo - Z. Tóth-Bagi - T. Dietrich - S. Milleri - D. Torres-Lagares - C. M. H

Fuente: https://link.springer.com/







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