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 molars according to the Pell and Gregory classification.
• Healthy subjects or with history of controlled chronic non-communicable diseases or that can be controlled prior to surgery, which, in the investigator's opinion, do not represent an additional risk for the patient.
• Patients who, at the investigator's discretion, meet personal and family conditions that allow them to properly comply with the activities described in the protocol and adherence to treatment.

Exclusion criteria

• Findings in the clinical history, vital signs, physical examination or laboratory studies suggesting abnormal conditions which represent a risk for subject's health at the investigator´s discretion.
• Hypersensitivity to any of the active ingredients and/or excipients of the investigational drugs.
• Patients with active peptic or gastroduodenal ulcer or diagnosis 30 days prior to signing the informed consent.
• Patients with history of allergic asthma reactions.
• Patients with severe hepatic dysfunction, classified as Child Pugh C or when being less, 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, hypertension or uncontrolled diabetes mellitus).
• Patients with a history of systemic neoplastic diseases or under treatment with chemotherapy.
• 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 2 weeks 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 least five half-lives prior to surgery.
• Patients with history of seizures or who are under treatment with medications that reduce the seizure threshold and who, according to medical criteria, cannot carry out a withdrawal scheme within 30 days prior to surgery.
• Positive pregnancy test or lactating women.
• Positive rapid urine drug test.