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

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

Official Title
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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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: TIRADENTES ASSOCIATION
* Drug: DIPYRONE
* Drug: TRAMADOL
* Other: TIRADENTES ASSOCIATION PLACEBO
* Other: DIPYRONE PLACEBO
* Other: TRAMADOL PLACEBO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIRADENTES<br>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. | Drug: TIRADENTES ASSOCIATION<br>* Tiradentes association tablet<br>Other: DIPYRONE PLACEBO<br>* Dipyrone placebo tablet<br>Other: TRAMADOL PLACEBO<br>* Tramadol placebo capsule<br>|
| Active Comparator: DIPYRONE<br>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. | Drug: DIPYRONE<br>* Dipyrone 500 mg<br>Other: TIRADENTES ASSOCIATION PLACEBO<br>* Tiradentes association placebo tablet<br>Other: TRAMADOL PLACEBO<br>* Tramadol placebo capsule<br>|
| Active Comparator: TRAMADOL<br>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. | Drug: TRAMADOL<br>* Tramadol 50 mg<br>Other: TIRADENTES ASSOCIATION PLACEBO<br>* Tiradentes association placebo tablet<br>Other: DIPYRONE PLACEBO<br>* Dipyrone placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6) | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study. |  | 26 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pain