Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

Phase IV and low-intervention trial To evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions.

The main evaluation variable: This is a simple study, which does not differ from standard clinical practice and therefore we do not expect early ending of the study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Collaborators: Hospital San Carlos, Madrid; Hospital Universitario de Burgos; Hospital Universitario Fundación Jiménez Díaz; Hospital Universitario La Paz; Hospital Universitario Ramon y Cajal; Hospital Universitario San Juan de Alicante; Puerta de Hierro University Hospital
• Treatments: Dexketoprofen trometamol; Tramadol

Criteria

Inclusion Criteria:

• Men or women over 18 years of age.

• 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.

• Patients who agree to participate in the study and give written consent.

Exclusion Criteria:

• Patients under treatment with other drugs that can inhibit CYP2D6, or are contraindicated in combination with tramadol or dexketoprofen.

• Patients on treatment with bisphosphonates.

• Patients who are receiving analgesic treatment before the operation, 24 hours prior to the operation. This criterion will be evaluated at the intervention visit.

• Patients suffering from other uncontrolled diseases.

• Pregnant or breastfeeding women.

• Patients with contraindications for treatment with tramadol or dexketoprofen.