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

NCT ID: NCT05167591

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-03-04

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).

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study group

Measurements of paracetamol concentration

Group Type: EXPERIMENTAL

Drug concentration measurement

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Drug concentration measurement

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johanna Kujala

OTHER

Sponsor Role: lead

Responsible Party

Johanna Kujala

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eija Kalso

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Other Identifiers

FEPODPara2021-1

Identifier Type: -

Identifier Source: org_study_id