dc.creator | Moore, R. Andrew | es |
dc.creator | Gay-Escoda, C. | es |
dc.creator | Figueiredo, R. | es |
dc.creator | Tóth-Bagi, Z. | es |
dc.creator | Dietrich, T. | es |
dc.creator | Milleri, S. | es |
dc.date.accessioned | 2024-07-10T15:54:43Z | |
dc.date.available | 2024-07-10T15:54:43Z | |
dc.date.issued | 2015 | |
dc.identifier.citation | Moore, R.A., Gay-Escoda, C., Figueiredo, R., Tóth-Bagi, Z., Dietrich, T. y Milleri, S. (2015). Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain. Journal of headache and pain, 16, 1-13. https://doi.org/10.1186/s10194-015-0541-5. | |
dc.identifier.issn | 1129-2369 | es |
dc.identifier.issn | 1129-2377 | es |
dc.identifier.uri | https://hdl.handle.net/11441/161272 | |
dc.description.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 (12.5 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.
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 (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.
Conclusions: Dexketoprofen 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 formula. | es |
dc.format | application/pdf | es |
dc.format.extent | 13 p. | es |
dc.language.iso | eng | es |
dc.publisher | Springer | es |
dc.relation.ispartof | Journal of headache and pain, 16, 1-13. | |
dc.rights | Atribución 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Dexketoprofen | es |
dc.subject | Tramadol | es |
dc.subject | Combination analgesics | es |
dc.subject | Postoperative pain | es |
dc.subject | Third molar | es |
dc.subject | Randomised controlled trial | es |
dc.subject | Dose range | es |
dc.title | Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Estomatología | es |
dc.contributor.affiliation | Instituto de Biomedicina de Sevilla (IBIS) | es |
dc.relation.publisherversion | https://thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-015-0541-5 | es |
dc.identifier.doi | 10.1186/s10194-015-0541-5 | es |
dc.contributor.group | Universidad de Sevilla. CTS523: Innovación y desarrollo en técnicas y fundamentos de cirugía bucal y craneofacial. | es |
dc.journaltitle | Journal of headache and pain | es |
dc.publication.volumen | 16 | es |
dc.publication.initialPage | 1 | es |
dc.publication.endPage | 13 | es |