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NCT05657704
Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol
Conditions: Post-surgical Pain, Pain, Acute, Postoperative Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 300
Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Location: Spain
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 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.
Source: ClinicalTrials.gov (NCT05657704). StuddyBuddy aggregates publicly available trial information.