Comparative study of analgesic efficacy between phosphate codeine in combination with paracetamol and oxycodone hydrochloride, after extractions of impacted lower third molars

INTERVENTION: E04.545.700 This is a clinical, prospective, randomized, double‐blind, split‐mouth study applied to a sample of 18 patients in need of bilateral lower third molar extraction with similar bone impaction. The patients in the test group and in the control group were submitted to a unilateral tooth extraction and then inverted, guaranteeing the crossover study criteria. All patients received only an anti‐inflammatory dose of 8mg of dexamethasone orally, 1 hour before surgery, to control edema and trismus, and antibiotics were not prescribed pre‐ or postoperatively. All extractions were performed by a single maxillofacial surgeon, at two different times, with a minimum interval of 21 days. On one side, patients received 10mg of oxycodone (control group). On the contralateral side, the patient received an association of 30mg of codeine phosphate and 500mg of paracetamol (test group). For both groups, a dose of 500mg of paracetamol was used as rescue medication. The medications were handled in identical capsules (same color, shape and size), stored in sealed bottles, containing 24 tablets. After unilateral extraction, the patient received bottles labeled with the letters A, B and C, while in contralateral extraction, he received bottles D, E and F. Patients received the first pill (A or D) immediately after the surgery. instructed to regularly use 1 tablet (B or E) at intervals of 6 hours, in alternation (AB or DE) until complete cessation of pain. In case the patient presented unbearable pain or unacceptable side effects, the C or F bottles that corresponded to the rescue medication should be used. This dosage was used to equalize the administration time between the dosage of 10mg of oxycodone (12h‐12h) and the dosage of 30mg of codeine (6‐6h), respecting the package inserts for these me CONDITION: 13896 postoperative pain PRIMARY OUTCOME: It is expected to find that the dosage of 30mg of codeine phosphate in association with 500mg of paracetamol has highter analgesic efficacy than the dosage of 10mg of oxycodone after impacted lower third molar extractions. SECONDARY OUTCOME: It is expected to find that the dosage of 30mg of codeine phosphate in combination with 500mg of acetaminophen is expected to have fewer side effects than a 10mg dosage of oxycodone after impacted lower third molar extractions. INCLUSION CRITERIA: Patientes of both sexes; aged over 18; with similar dental impaction; absence of systemic diseases or locoregional changes; without contraindication to the use of dexamethasone, paracetamol, codeine phosphate or oxycodone; absence of a history of hypersensitivity to mepivacaine.