Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Tiradentes association in adolescents and adults with acute pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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. |
Drug: TIRADENTES ASSOCIATION
Tiradentes association tablet
Other: DIPYRONE PLACEBO
Dipyrone placebo tablet
Other: TRAMADOL PLACEBO
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. |
Drug: DIPYRONE
Dipyrone 500 mg
Other: TIRADENTES ASSOCIATION PLACEBO
Tiradentes association placebo tablet
Other: TRAMADOL PLACEBO
Tramadol placebo capsule
|
| 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. |
Drug: TRAMADOL
Tramadol 50 mg
Other: TIRADENTES ASSOCIATION PLACEBO
Tiradentes association placebo tablet
Other: DIPYRONE PLACEBO
Dipyrone placebo tablet
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Incidence and severity of adverse events recorded during the study. [26 days]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- EMS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EMS1519 - TIRADENTES 500/50