Conditions: Pain
Keywords: Moderate to severe pain Postoperative pain Analgesics Dexketoprofen Tramadol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 745
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.

Detailed description:
The aim of this study is to develop a combination of Dexketoprofen Trometamol (DKP.TRIS) and Tramadol Hydrochloride (TRAM.HCl) for the treatment of acute moderate to severe pain, based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain, particularly of moderate to severe intensity.

DKP.TRIS and TRAM.HCl have different mechanisms of action, therefore their combination is expect to result in an additive or synergistic analgesia, thus allowing a decrease in the required doses of the individual agents, and consequently a reduced risk of adverse events In this study, patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKP.TRIS + TRAM.HCl, the four corresponding single treatments, placebo and ibuprofen. Treatment administration will be followed by a 24-hour pain and analgesic effect assessment.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None

Interventions: intervention 1: Dexketoprofen Trometamol intervention 2: Dexketoprofen Trometamol intervention 3: Tramadol Hydrochloride intervention 4: Tramadol Hydrochloride intervention 5: Ibuprofen intervention 6: Placebo intervention 7: Dexketoprofen Trometamol + Tramadol Hydrochloride intervention 8: Dexketoprofen Trometamol + Tramadol Hydrochloride intervention 9: Dexketoprofen Trometamol + Tramadol Hydrochloride intervention 10: Dexketoprofen Trometamol + Tramadol Hydrochloride
Intervention descriptions: intervention 1: Dexketoprofen Trometamol low dose, oral film-coated table, once intervention 2: Dexketoprofen Trometamol high dose, oral film-coated table, once intervention 3: Tramadol Hydrochloride low dose, oral film-coated table, once intervention 4: Tramadol Hydrochloride high dose, oral film-coated table, once intervention 5: Ibuprofen 400 mg, oral film-coated table, once intervention 6: Placebo, oral film-coated table, once intervention 7: DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once intervention 8: DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once intervention 9: DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once intervention 10: DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once

Protocol document: