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

EMS

Status and phase: Withdrawn; Phase 2

Conditions: Acute Pain

Treatments: Drug: TRAMADOL; Drug: TIRADENTES ASSOCIATION; Drug: DIPYRONE; Other: TIRADENTES ASSOCIATION PLACEBO; Other: DIPYRONE PLACEBO; Other: TRAMADOL PLACEBO

Study type: Interventional

Funder types: Industry

Identifiers

NCT04593329

EMS1519 - TIRADENTES 500/50

Details and patient eligibility

About

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

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

TIRADENTES

Experimental group

Description:

The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 tablet Tiradentes association, oral; 1 capsule tramadol placebo, oral; 1 tablet dipyrone placebo, oral.

Treatment:

Drug: TIRADENTES ASSOCIATION

Other: TRAMADOL PLACEBO

Other: DIPYRONE PLACEBO

DIPYRONE

Active Comparator group

Description:

The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 tablet dipyrone, oral; 1 tablet Tiradentes association placebo, oral; 1 capsule tramadol placebo, oral.

Treatment:

Other: TIRADENTES ASSOCIATION PLACEBO

Other: TRAMADOL PLACEBO

Drug: DIPYRONE

TRAMADOL

Active Comparator group

Description:

The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 capsule tramadol, oral; 1 tablet dipyrone placebo, oral; 1 tablet Tiradentes association placebo, oral.

Treatment:

Drug: TRAMADOL

Other: TIRADENTES ASSOCIATION PLACEBO

Other: DIPYRONE PLACEBO