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

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Dipyrone; Tramadol

Criteria

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.