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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

TIRADENTES ASSOCIATION

Intervention Type DRUG

Tiradentes association tablet

DIPYRONE PLACEBO

Intervention Type OTHER

Dipyrone placebo tablet

TRAMADOL PLACEBO

Intervention Type OTHER

Tramadol placebo capsule

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.

Group Type ACTIVE_COMPARATOR

DIPYRONE

Intervention Type DRUG

Dipyrone 500 mg

TIRADENTES ASSOCIATION PLACEBO

Intervention Type OTHER

Tiradentes association placebo tablet

TRAMADOL PLACEBO

Intervention Type OTHER

Tramadol placebo capsule

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.

Group Type ACTIVE_COMPARATOR

TRAMADOL

Intervention Type DRUG

Tramadol 50 mg

TIRADENTES ASSOCIATION PLACEBO

Intervention Type OTHER

Tiradentes association placebo tablet

DIPYRONE PLACEBO

Intervention Type OTHER

Dipyrone placebo tablet

Interventions

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TIRADENTES ASSOCIATION

Tiradentes association tablet

Intervention Type DRUG

DIPYRONE

Dipyrone 500 mg

Intervention Type DRUG

TRAMADOL

Tramadol 50 mg

Intervention Type DRUG

TIRADENTES ASSOCIATION PLACEBO

Tiradentes association placebo tablet

Intervention Type OTHER

DIPYRONE PLACEBO

Dipyrone placebo tablet

Intervention Type OTHER

TRAMADOL PLACEBO

Tramadol placebo capsule

Intervention Type OTHER

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.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No