Pain
Conditions
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREVenopuncture for PK profiling
Blood samples at T0, T0.5, T1, T2, T4, T6
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of the pharmacokinetic parameters: AUC | 8 hours (= during 1 dosing interval at steady state) | Area under the curve (AUC) |
| Identification of the pharmacokinetic parameters: Cmax | 8 hours (= during 1 dosing interval at steady state) | Peak plasma concentration after administration of paracetamol (Cmax) |
| Identification of the pharmacokinetic parameters: Tmax | 8 hours (= during 1 dosing interval at steady state) | The time at which the Cmax is observed (Tmax) of paracetamol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The association between the AUC (area under the curve) of paracetamol and patient related factors. | 8 hours (= during 1 dosing interval at steady state) | Multivariate analysis will be performed with AUC (area under the curve) as outcome. This will allow to identify variables influencing AUC of paracetamol. Patient related factors include amongst others age, weight, albumin, bilirubin, serum creatinin and co medication. |
| Variability in plasma exposure: Vd | 8 hours (= during 1 dosing interval at steady state) | Volume of distribution (Vd) |
| Correlation between immuno assay method and the Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine paracetamol concentrations in serum | 8 hours (= during 1 dosing interval at steady state) | Correlation between two different assays will be determined through Bland Altman statistics. |
| The association between the AUC (area under the curve) of paracetamol and pain scores. | 8 hours (= during 1 dosing interval at steady state) | Pain scores will be based on the Numeric Rating Scale with a score of 0 indicating no pain and a score of 10 indicating worst imaginable pain. |
| Variability in plasma exposure: t1/2 | 8 hours (= during 1 dosing interval at steady state) | Elimination half-life (t1/2) |
| Variability in plasma exposure: Cl | 8 hours (= during 1 dosing interval at steady state) | Clearance (Cl) |
Countries
Belgium
Outcome results
None listed