Postoperative Pain Clinical Trial
— Tradol-PriMEOfficial title:
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.
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario San Juan de Alicante | Alicante | |
Spain | Hospital General Universitario de Burgos y Clínica Colina | Burgos | |
Spain | Fundación para la Investigación Biomédica Hospital La Princesa | Madrid | |
Spain | Hospital Universitario Clínico San Carlos | Madrid | |
Spain | Hospital Universitaro La Paz | Madrid | |
Spain | Hospital Univesitario Ramón y Cajal | Madrid | |
Spain | Hostpital Universitario Fundación Jiménez Díaz | Madrid | |
Spain | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid |
Lead Sponsor | Collaborator |
---|---|
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | 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 |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy: analgesic effect (Pain assessment) 4 hours after treatment | To evaluate the analgesic effect (pain assessment) that will be evaluated throughout visual analogical scale (VAS) from 0 to 100. | 4 hour after treatment | |
Secondary | Efficacy at the end of treatment | Efficacy will also be evaluated based on the requirement of the study medication, if treatment has been completed during the three days (recommended in the study protocol), or on the contrary, three days of treatment have not been required due to pain remission; the requirement of rescue medication due to lack of efficacy of the prescribed treatments in the first 24 hours after the administration of the first dose. Time to rescue medication use will also be measured. | 3 days after treatment administration (72 Hours) | |
Secondary | Correlation between efficacy and the pharmacokinetic parameters (AUC) | The efficacy of the treatments will be analyzed and whether these correlate with the pharmacokinetic parameters (AUC) for each patient, calculated from the quantified plasma concentrations of tramadol and metabolite1 of tramadol (samples 2 hour and 4h) or dexketoprofen (samples 1h and 4h). | 1 hours, 2 hours and 4 hours | |
Secondary | Correlation between efficacy and pharmacogenetic profile (focus in CYP2D6) | The efficacy of the treatments will be analyzed with the pharmacogenetic profile of the patients, that is, if the pharmacokinetic profile, Tmax and AUC, correlates with the enzymatic activity rate for the CYP2D6 phenotype (Activity Score - AS) of poor metabolizer (AS-0), intermediate metabolizer (AS: between 0 and 1.25), normal metabolizer ( AS: between 1.25 and 2.25) or ultrarapid metabolizer (AS > 2.25) | Through study completion, an average of 1 year and 6 months | |
Secondary | Safety evaluations | The safety evaluations will be carried out in accordance with the Good Clinical Practice Standards and current legislation. The safety of the treatments will be analyzed with the pharmacogenetic profile of the patients | Through study completion, an average of 1 year and 6 months |
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