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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Diagnostic Test: Drug concentration measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Measurements of paracetamol concentration | Diagnostic Test: Drug concentration measurement<br>* Measurement of paracetamol concentration in capillary, venous plasma and saliva samples after standard premedication with paracetamol<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrochemical, Paracetamol, Saliva, Fingerprick, Capillary sample, Acetaminophen