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

Last updated: December 11, 2022
Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Overall Status: Active - Recruiting

Phase

4

Condition

Post-surgical Pain

Chronic Pain

Pain

Treatment

N/A

Clinical Study ID

NCT05657704
2022-500377-13-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women over 18 years of age.
  • Patients scheduled for outpatient surgical extraction, under local anesthesia, of atleast 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

Exclusion Criteria:

  • Patients under treatment with other drugs that can inhibit CYP2D6, or arecontraindicated in combination with tramadol or dexketoprofen.
  • Patients on treatment with bisphosphonates.
  • Patients who are receiving analgesic treatment before the operation, 24 hours prior tothe 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.

Study Design

Total Participants: 300
Study Start date:
October 05, 2022
Estimated Completion Date:
December 31, 2023

Study Description

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 The main objective is evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions. Secondary objectives: 1. To evaluate whether treatment adjusted according to CYP2D6 phenotype can reduce adverse reactions to tramadol in acute postoperative pain. 2. To compare the efficacy and safety of dexketoprofen and tramadol in the treatment of acute postoperative pain. 3. To investigate the influence on analgesic response and the incidence of adverse reactions of polymorphisms of other genes involved in the pharmacokinetics and mechanism of action of dexketoprofen and tramadol, such as: CYP2C9, CYP2C8, CYP2C19, CYP3A4, CYP3A5, CYP2B6, CYP2E1, COMT, ABCB1, SLC22A1, OPRM1 and PTGS2. 4. To evaluate the relationship of tramadol, M1 and dexketoprofen plasma concentrations with response to treatment and the occurrence of adverse reactions.

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.

Connect with a study center

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28220
    Spain

    Site Not Available

  • Hospital Universitario San Juan de Alicante

    Alicante, 03550
    Spain

    Site Not Available

  • Hospital General Universitario de Burgos y Clínica Colina

    Burgos, 09006
    Spain

    Active - Recruiting

  • Fundación para la Investigación Biomédica Hospital La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitaro La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Univesitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hostpital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

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