Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain

Inclusion Criteria:

• Patients of both sexes aged from 18 to 40 years.

• Patients who agreed to participate in the study by signing the informed consent.

• Patients with indication for surgical extraction of impacted lower third molarsaccording to the Pell and Gregory classification.

• Healthy subjects or with history of controlled chronic non-communicable diseases orthat can be controlled prior to surgery, which, in the investigator's opinion, donot represent an additional risk for the patient.

• Patients who, at the investigator's discretion, meet personal and family conditionsthat allow them to properly comply with the activities described in the protocol andadherence to treatment.

Exclusion Criteria:

• Findings in the clinical history, vital signs, physical examination or laboratorystudies suggesting abnormal conditions which represent a risk for subject's healthat the investigator´s discretion.

• Hypersensitivity to any of the active ingredients and/or excipients of theinvestigational drugs.

• Patients with active peptic or gastroduodenal ulcer or diagnosis 30 days prior tosigning the informed consent.

• Patients with history of allergic asthma reactions.

• Patients with severe hepatic dysfunction, classified as Child Pugh C or when beingless, the investigator considers it an additional risk for patients.

• Patients with a creatinine clearance <30 mL/min.

• Patients with coagulation disorders.

• Patients with Systemic Lupus Erythematosus.

• Patients with congestive heart failure (NYHA class II-IV), ischemic heart disease,peripheral arterial disease, or cerebrovascular disease who have recently (3 months)undergone coronary artery bypass grafting or angioplasty procedures.

• Patients at high risk of acute cardiovascular events (intense smoking, hypertensionor uncontrolled diabetes mellitus).

• Patients with a history of systemic neoplastic diseases or under treatment withchemotherapy.

• Patients with a history of illicit drug abuse or addiction to alcohol or tobacco.

• Patients with monoamine oxidase inhibitors (MAOIs) treatment or during the last 2weeks prior to the study drug administration.

• Patients with opioid analgesics, neuromodulators, or long-acting NSAIDs therapy who,according to medical criteria, cannot carry out a withdrawal scheme for at leastfive half-lives prior to surgery.

• Patients with history of seizures or who are under treatment with medications thatreduce the seizure threshold and who, according to medical criteria, cannot carryout a withdrawal scheme within 30 days prior to surgery.

• Positive pregnancy test or lactating women.

• Positive rapid urine drug test.