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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04593329

Enrollment

Registered

2020-10-20

Start date

2023-03-31

Completion date

2023-12-31

Last updated

2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

Acute Pain

Brief summary

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

Interventions

DRUGTIRADENTES ASSOCIATION

Tiradentes association tablet

DRUGDIPYRONE

Dipyrone 500 mg

DRUGTRAMADOL

Tramadol 50 mg

OTHERTIRADENTES ASSOCIATION PLACEBO

Tiradentes association placebo tablet

OTHERDIPYRONE PLACEBO

Dipyrone placebo tablet

OTHERTRAMADOL PLACEBO

Tramadol placebo capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Incidence and severity of adverse events recorded during the study.	26 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026