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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04593329
• Other study ID #: EMS1519 - TIRADENTES 500/50
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2023
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• TIRADENTES ASSOCIATION
Tiradentes association tablet
• DIPYRONE
Dipyrone 500 mg
• TRAMADOL
Tramadol 50 mg

Other:
• TIRADENTES ASSOCIATION PLACEBO
Tiradentes association placebo tablet
• DIPYRONE PLACEBO
Dipyrone placebo tablet
• TRAMADOL PLACEBO
Tramadol placebo capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence and severity of adverse events recorded during the study.		26 days