Paracetamol toxicity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Admitted to the geriatric trauma unit (OLVG West) (post-operative acute hip fracture patients) - Age =70 years - Received a Fascia Iliaca Compartiment Block (FICB) on admission on the ER (hospital standard of care protocol acute hip fracture) - Written informed consent by patient or legal representative
Exclusion criteria
Exclusion criteria: - Use of paracetamol in 72 hours prior to admission - Exclusion criteria for FICB: complicated fractures, femoral nerve damage, bupivacaine/ levobupivacaine allergy, infections in pelvic area, anti-coagulation therapy, INR > 4,5, history of femoral bypass surgery, planned operation 2.5 x upper limit of normal) - Alcoholism (= 2 units of alcohol per day) - Difficulty in donating blood or limited accessibility of a vein - Use of tobacco products (causing induction CYP1A2) in 7 days prior to admission. - Use of other CYP inducers/inhibitors which may have impact on acetaminophen metabolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the patient group treated with paracetamol: Difference in pharmacokinetic parameters of acetaminophen and six of its metabolites (APAP-Glc, APAP-Sul, APAP-OMe, APAP-GSH, APAP-Cys, and APAP-Cys-NAC) following the administration of paracetamol four times daily after 24 hours and 120 hours of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The correlation between pharmacokinetic parameters of APAP and metabolites and levels of MiR-122. Furthermore, miR-122 levels of the patients treated with FICB and paracetamol will be compared with patients who received FICB only. | — |
Contacts
UMCU