Safety of paracetamol in older adults

Conditions: bijwerking van medicatie
acetaminophen use
safety

Registration Number: NL-OMON50956

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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

- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In the patient group treated with paracetamol: Difference in pharmacokinetic<br /><br>parameters of acetaminophen and six of its metabolites (APAP-Glc, APAP-Sul,<br /><br>APAP-OMe, APAP-GSH, APAP-Cys, and APAP-Cys-NAC) following the administration of<br /><br>paracetamol four times daily after 24 hours and 120 hours of treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the correlation between pharmacokinetic parameters<br /><br>of APAP and metabolites and levels of MiR-122. Furthermore, miR-122 levels of<br /><br>the patients treated with FICB and paracetamol will be compared with patients<br /><br>who received FICB only. </p><br>