Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
Condition: Pain
Intervention: Dexketoprofen Trometamol; Dexketoprofen Trometamol; Tramadol Hydrochloride; Tramadol Hydrochloride; Ibuprofen; Placebo; Dexketoprofen Trometamol + Tramadol Hydrochloride; Dexketoprofen Trometamol + Tramadol Hydrochloride; Dexketoprofen Trometamol + Tramadol Hydrochloride; Dexketoprofen Trometamol + Tramadol Hydrochloride
Intervention description: Dexketoprofen Trometamol low dose, oral film-coated table, once; Dexketoprofen Trometamol high dose, oral film-coated table, once; Tramadol Hydrochloride low dose, oral film-coated table, once; Tramadol Hydrochloride high dose, oral film-coated table, once; Ibuprofen 400 mg, oral film-coated table, once; Placebo, oral film-coated table, once; DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once; DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once; DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once; DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once
Intervention MeSH terms: Ibuprofen; Dexketoprofen trometamol; Ketoprofen; Tramadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 745.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Moderate to severe pain; Postoperative pain; Analgesics; Dexketoprofen; Tramadol

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients meeting ALL the following criteria will be eligible for entry into the study:

          -  Male or female patients aged 18 to 70 years old. Females participating in the study
             must be either: of non-childbearing potential, or willing to use a highly effective
             contraceptive method.

          -  Scheduled for outpatient surgical extraction -under local anaesthesia- of third
             mandibular molar teeth, with at least one of which is fully or partially impacted in
             the mandible requiring bone manipulation.

          -  Normal physical examination or without clinically relevant abnormalities.

        At randomisation (after surgery):

        No intake of analgesics (including prescription and over the counter drugs) within 24h
        prior to the surgery.

          -  No complication during the surgery, duration of surgery < 1 hour and not requiring
             re-anaesthesia.

          -  Patients experiencing pain of moderate or higher intensity in the first four hours
             after the end of surgery.

        Exclusion Criteria:

          -  History of allergy or hypersensitivity to NSAIDs, opioids or acetyl salicylic acid.

          -  History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or
             angioneurotic oedema.

          -  History of peptic ulcer, gastrointestinal disorders by NSAIDs, gastrointestinal
             bleeding or other active bleedings.