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

September 5, 2023 updated by: EMS

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.

Study Overview

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIRADENTES

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.

Tiradentes association tablet
Dipyrone placebo tablet
Tramadol placebo capsule
Active Comparator: 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.

Tramadol placebo capsule
Dipyrone 500 mg
Tiradentes association placebo tablet
Active Comparator: 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.

Dipyrone placebo tablet
Tiradentes association placebo tablet
Tramadol 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6)
Time Frame: 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.
0-6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded during the study.
Time Frame: 26 days
26 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2023

Primary Completion (Estimated)

August 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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