SAfety of PARacetamol in OLDer adults

Conditions: Paracetamol toxicity

Registration Number: NL-OMON20003

Lead Sponsor: MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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

-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 < 60 minutes of ER admission, peripheral neuropathy with sensory loss.
-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.
-Use of other CYP inducers/inhibitors which may have impact on acetaminophen metabolism.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.