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SAfety of PARacetamol in OLDer adults

SAfety of PARacetamol in OLDer adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20003
Enrollment
20
Registered
2021-05-16
Start date
2021-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paracetamol toxicity

Interventions

Venipunctures for APAP metabolite and MiR-122 assays (otherwise standard of care post-operative paracetamol pain treatment).

Sponsors

UMCU
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactHiltsje Heemskerk

UMCU

h.y.heemskerk-2@umcutrecht.nl0642412837

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)