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- PMID: 26123824
- UKPMCID: 26123824
- DOI: 10.1186/s10194-015-0541-5
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Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain.
Moore, R Andrew; Gay-Escoda, C; Figueiredo, R; Tóth-Bagi, Z; Dietrich, T; Milleri, S; Torres-Lagares, D; Hill, C M; GarcÃa-GarcÃa, A; Coulthard, P; Wojtowicz, A; Matenko, D; Peñarrocha-Diago, M; Cuadripani, S; Pizà -Vallespir, B; Guerrero-Bayón, C; Bertolotti, M; Contini, M P; Scartoni, S; Nizzardo, A; Capriati, A; Maggi, C A
The journal of headache and pain. 2015;16:541.
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Full-text held externally
- PMID: 26123824
- UKPMCID: 26123824
- DOI: 10.1186/s10194-015-0541-5
Abstract
BACKGROUND: Combination 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. METHODS: This 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 (12.5Â mg and 25Â mg) and tramadol hydrochloride (37.5Â mg and 75Â mg), given as four different fixed combinations and single components, with ibuprofen 400Â 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 50Â % max TOTPAR over six hours. RESULTS: 606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders (72Â %) was achieved in the dexketoprofen trometamol 25Â mg plus tramadol hydrochloride 75Â mg group (NNT 1.6, 95Â % 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 8.1Â h). Adverse events were unremarkable. CONCLUSIONS: Dexketoprofen trometamol 25Â mg combined with tramadol hydrochloride 75Â 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 REGISTRATION: EudraCT (2010-022798-32); Clinicaltrials.gov ( NCT01307020 ).
Bibliographic metadata
- Moore, R Andrew
- Gay-Escoda, C
- Figueiredo, R
- Tóth-Bagi, Z
- Dietrich, T
- Milleri, S
- Torres-Lagares, D
- Hill, C M
- GarcÃa-GarcÃa, A
- Coulthard, P
- Wojtowicz, A
- Matenko, D
- Peñarrocha-Diago, M
- Cuadripani, S
- Pizà -Vallespir, B
- Guerrero-Bayón, C
- Bertolotti, M
- Contini, M P
- Scartoni, S
- Nizzardo, A
- Capriati, A
- Maggi, C A