Randomized clinical trial to evaluate the utility of CYP2D6 genotyping to improve the efficacy and safety of tramadol in the treatment of acute postoperative pai

Phase 1

Recruiting

• Conditions: Pharmakogenetics, Therapeutic techniques in treatment of acute postoperative pain; Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: CTIS2022-500377-13-01
• Lead Sponsor: Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Men or women over 18 years of age., 2. Patients scheduled for outpatient surgical extraction, under local anesthesia, of at least two impacted third molars, at least one of which will require bone removal., 3. Patients who agree to participate in the study and give written consent.

Exclusion Criteria

1. Patients under treatment with other drugs that can inhibit CYP2D6, or are contraindicated in combination with tramadol or dexketoprofen., 2. Patients on treatment with bisphosphonates., 3. Patients who are receiving analgesic treatment before the operation, 24 hours prior to the operation. This criterion will be evaluated at the intervention visit., 4. Patients suffering from other uncontrolled diseases., 5. Pregnant or breastfeeding women., 6. Patients with contraindications for treatment with tramadol or dexketoprofen.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified