Tramadol premedication in operative extraction of the mandibular third molar: a placebo-controlled crossover study.

Anxiolytic drugs are widely used for premedication in oral surgery. Since anxiety is usually associated with the fear of pain, we tested the effects of the analgesic tramadol in premedication before operative extraction of the mandibular third molar under local anesthesia. In a double-blind crossover study, 20 patients were randomized to receive 100 mg oral tramadol or placebo 1 h before operation. Anxiety, nausea, dryness of the mouth, pain and discomfort were recorded before administration of the drug, immediately before and after operation, and 0.5, 1, and 2 h postoperatively using ungraded 0-100 mm VAS scales. Blood pressure and heart rate were measured at the same times; vigilance was tested using the Maddox Wing Test and sensorimotor performance using the Trieger Dot Test; hemoglobin oxygen saturation (SpO2) was measured using a pulse oximeter. In addition, SpO2 and heart rate were recorded continuously in nine patients using a pulse oximeter connected to a computer. The surgeon assessed the quality of operating conditions on the VAS scale. Tramadol delayed and decreased the need of analgesics on the day of operation (p < 0.05). The operating conditions were better in patients on tramadol premedication than in those on placebo during the first operation (p < 0.05), but no differences were seen in patient well-being between treatments. The second operation was less stressful than the first. Tramadol is recommended only with special indications for premedication of patients undergoing third molar extraction under local anesthesia.

RCT Entities:   Population Interventions Outcomes