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

Phase 2

Withdrawn

• Conditions: Acute Pain
• Interventions: Drug: TIRADENTES ASSOCIATION; Drug: TRAMADOL; Drug: DIPYRONE; Other: TIRADENTES ASSOCIATION PLACEBO; Other: DIPYRONE PLACEBO; Other: TRAMADOL PLACEBO

• Registration Number: NCT04593329
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Study Start: 2023-03
• Primary Completion: 2023-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIRADENTES	TIRADENTES ASSOCIATION	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.
TRAMADOL	DIPYRONE PLACEBO	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.
TRAMADOL	TRAMADOL	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.
TIRADENTES	TRAMADOL PLACEBO	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.
DIPYRONE	DIPYRONE	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.
DIPYRONE	TIRADENTES ASSOCIATION PLACEBO	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.
TIRADENTES	DIPYRONE PLACEBO	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.
DIPYRONE	TRAMADOL PLACEBO	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.
TRAMADOL	TIRADENTES ASSOCIATION PLACEBO	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.

Primary Outcome Measures

Name	Time	Method
Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6)	0-6 hours	Sum of pain intensity differences after 6 hours (SPID0-6), calculated as the weighted sum of pain intensity scale over 6 hours after the dose. Scoring is derived from the 4-point scale, which 0= no pain, 1= mild pain, 2= moderate pain and 4= severe pain.

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events recorded during the study.	26 days