Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain

National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain

The purpose of this study is to evaluate the efficacy and safety of Tiradentes association in adolescents and adults with acute pain.

Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Participants of both sexes, aged 15 years or more;
• Participants who require extraction of impacted mandibular third molar;
• Third molar with bone impactions observed in panoramic radiography, with classification of Winter (1926) mesioangular or vertical, and classification according to Pell & Gregory (1933) class II position B or class III position A or B;
• Participants with acute pain of moderate or severe intensity after completion of surgery.

Exclusion Criteria:

• Known hypersensitivity to the formula components used during the clinical trial;
• History of alcohol and/or substance abuse within 2 years;
• Participants whose surgery for molar extraction lasted more than 50 minutes;
• Participants with known gastroduodenal ulcers or diagnosis of persistent gastritis;
• Participants who used sedatives or hypnotic agents before surgery;
• Anesthesia technical failure or need for more than three anesthetic tubes;
• Participants with temporomandibular joint dysfunction or limited mouth opening;
• Surgical accident that, in the investigator's opinion, may interfere with the procedures or evaluations of the trial;
• Postoperative complications such as, but not restricted to: neuropraxia and paresthesia;
• Participants who used any medication that acts on the pain mechanism in the 3 days prior to the start of the trial;
• Participants under chronic opioid treatment.