Detection of Paracetamol Concentration in Patients Using Regular Medication- a Validation Study for a Novel Technique

Determination of Serum Paracetamol Concentration With an Electrochemical Measurement Tool From Blood and Saliva Samples in Patients Using Also Other Medication.

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05167591

Enrollment

Registered

2021-12-22

Start date

2024-03-01

Completion date

2024-03-04

Last updated

2024-03-06

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

Conditions

Pharmacokinetics

Keywords

Electrochemical, Paracetamol, Saliva, Fingerprick, Capillary sample, Acetaminophen

Brief summary

Paracetamol intoxication is common, and concentration measurements are performed regularly. This research group is developing a fast bedside electrochemical analysis tool for paracetamol concentration measurement. This study will find out how this novel method performs in patients using other, confounding medication in detecting paracetamol concentration in capillary blood, venous plasma and saliva samples.

Detailed description

Paracetamol concentration analysis is performed in 20 patients who will come to hospital for elective surgery. Inclusion criteria is a regular medication that continues over perioperative period. Patients will be given standard premedication of paracetamol 1g perorally before surgery: this study does not affect standard surgical treatment. Paracetamol concentration will be measured in venous plasma-, capillary blood-, and saliva samples before drug delivery and in recovery room after surgery using the novel electrochemical analysis tool and high-performance mass spectrometry analysis as a reference. If needed, confounding medication is identified with large toxicologic mass spectrometry screen (UPLC-QTOF).

Interventions

DIAGNOSTIC_TESTDrug concentration measurement

Measurement of paracetamol concentration in capillary, venous plasma and saliva samples after standard premedication with paracetamol

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* informed consent * Age 18-75 years * American society of anesthesiologist classification 2-4 * planned elective surgery with standard premedication with paracetamol 1g po. * at least one regular medication ongoing perioperatively * eligibility for elective surgery * negative pregnancy test in fertile women

Exclusion criteria

* American society of anesthesiologists classification 1 * contraindication for use of paracetamol as standard premedication * pregnancy or lactation * less than 3 months from previous drug research * less than 3 months from previous blood donation * anticipated difficult puncture of veins * Body Mass Index lower than 18.5 or higher than 35

Design outcomes

Primary

Measure	Time frame	Description
No outcome for patients	24 hours	Comparison of paracetamol concentration (µmol/L) measurements in saliva-, plasma-, and capillary samples and between mass-spectrometry and electrochemical techniques.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026