Fixed Dose Combination of COdeine + DIpyrone to Mitigate Moderate to Intense Pain Post-impacted Third Lower Molar Extraction

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A clinical, multicenter, randomized, parallel-group, double-blind, double-dummy, comparative study of non-inferiority.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Codeine; Dipyrone

Criteria

Inclusion Criteria:

1. Aged between 16 and 35 years old (inclusive).

2. Presence of impacted third lower molar with surgical removal indicated (diagnosed via panoramic x-ray within six [6] months before inclusion in the study), at vertical, mesioangular or horizontal position as per the Winter's classification, provided that it belongs to the following Pell & Gregory's classes:

3. Maximum surgery duration of 30 minutes, counted from the initial incision to the impacted third molar extraction.

4. Moderate to intense postoperative pain (≥ 40 mm at a VAS of 0-100 mm) up to four (4) hours after the end of the surgery (counted from the end of the suture).

5. Informed Consent Form (ICF) and Informed Assent Form (IAF) signature, when applicable, before performing any study procedure.

Exclusion Criteria:

1. Known hypersensitivity to dipyrone or to other pirazolones or pirazolidines (e.g.:

phenazone, propyphenazone, isopropylaminophenazone, phenylbutazone, oxyphenbutazone), including history of previous agranulocytosis with one of these substances;

2. Known hypersensitivity to codeine or to other opioid agents;

3. Known hypersensitivity to paracetamol or to any component of the Tylex® formulation;

4. Bone marrow function impairment (e.g.: after cytostatic treatment) or hematopoietic system diseases;

5. History of bronchospasm or other anaphylactoid reactions (e.g.: hives, rhinitis, angioedema) associated with the use of analgesics, such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen;

6. History of significant hypotensive reaction associated with the administration of dipyrone;

7. Abuse of illegal drugs, including alcoholism; emotional instability and/or previous attempt of suicide;

8. Pregnancy or breastfeeding.

9. Women of childbearing potential who do not agree to use a known effective birth control method, unless the participants are surgically sterile or state they are expressly free of the risk of getting pregnant for not having sexual intercourse or for having sexual intercourse with no reproductive potential.

10. Participation in a clinical research protocol within the past 12 months, unless the investigator considers that the participation in the study could result in a direct benefit to the subject.

11. Presence of any condition that, in the investigator's opinion, would make the subject ineligible to participate in the study.