Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Pain

Treatments: Procedure: Venopuncture for PK profiling

Study type: Interventional

Funder types: Other

Identifiers

NCT03617471

S58396 - mp05485

Details and patient eligibility

About

The goal of this exploratory study is the characterization of the pharmacokinetic (PK) profile of paracetamol in older patients and the specific PK (pharmacokinetic) variables associated with plasma exposure in this population.

Full description

The goal of this exploratory study is the characterization of the pharmacokinetic profile of paracetamol in older patients and the specific PK variables associated with plasma exposure in this population. The primary endpoint is the identification of the pharmacokinetic parameters: area under the curve (AUC), peak plasma concentration after administration of paracetamol (Cmax) and the time at which the Cmax is observed (Tmax) of paracetamol. The secondary endpoint consists of 3 sub-endpoints:

1. The variability in plasma exposure: volume of distribution (Vd), clearance (Cl) and elimination half-life (t1/2)
2. The association between the PK parameters and pathophysiological factors
3. The correlation between PK parameters and clinical parameters.

Enrollment: 36 patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• a minimum age of 80 years
• admission to the acute geriatrics ward
• oral intake of paracetamol 1000 milligram (mg) in tablet form tid
• a steady state situation (defined as at least 4 consecutive intakes of paracetamol before sampling)

Exclusion criteria

• palliative care setting with downgrading of care

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Paracetamol oral tablets 1g tid

Experimental group

Description:

Patients received paracetamol one gram three times daily. Venopuncture for PK profiling

Treatment:

Procedure: Venopuncture for PK profiling

Paracetamol oral granules 1g tid

Experimental group

Description:

Patients received paracetamol one gram three times daily. Venopuncture for PK profiling

Treatment:

Procedure: Venopuncture for PK profiling