Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol (Tradol-PriME)
Post-surgical Pain, Pain, Acute, Postoperative Pain
About this trial
This is an interventional treatment trial for Post-surgical Pain focused on measuring Pharmacogenetics, Therapeutic techniques in treatment of acute postoperative pain
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.
Sites / Locations
- Hospital Universitario Puerta de Hierro
- Hospital Universitario San Juan de Alicante
- Hospital General Universitario de Burgos y Clínica ColinaRecruiting
- Fundación para la Investigación Biomédica Hospital La PrincesaRecruiting
- Hospital Univesitario Ramón y Cajal
- Hospital Universitario Clínico San Carlos
- Hostpital Universitario Fundación Jiménez Díaz
- Hospital Universitaro La Paz
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
No Intervention
Experimental
Tramadol
Dexketoprofen
Experimental Group
Patients treated with Tramadol, 100 mg every 8 hours according to clinical practice for the treatment of postoperative pain.
Patients treated with Dexketoprofen 25 mg every 8 hours according to clinical practice for the treatment of postoperative pain.
The patients in this group will be genotyped before surgery and treatment will be prescribed according to the CYP2D6 phenotype. Normal Metabolizers (NM): Tramadol 100 mg every 8 hour; Ultrarapid Metabolizers (UM): Tramadol 50 mg every 8 hours Intermediate and poor metabolizers (IM/PM): dexketoprofen 25 mg every 8 hours