bijwerking van medicatie acetaminophen use safety
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: - (Intended) admission 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) or other adequate pain medication - Written informed consent by patient or witness when the patient is analphabetic and oral consent is given or legal representative
Exclusion criteria
Exclusion criteria: - Use of paracetamol in 72 hours prior to admission - Known allergy or contra indication for use of paracetamol (i.e. severe liver cirrhosis, G6PD deficiency) - Abnormalities in AST / ALT / Bilirubin / gGT / ALP (> 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 [27]. - Use of other CYP inducers/inhibitors which may have impact on acetaminophen metabolism. - Inability to understand and give informed consent due to (temporally) incapacitation
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 |
|---|---|
| Secondary endpoints include 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. | — |
Countries
Netherlands
Outcome results
None listed