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

March 4, 2024 updated by: Johanna Kujala

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Measurements of paracetamol concentration
Diagnostic test: Drug concentration measurement
Measurement of paracetamol concentration in capillary, venous plasma and saliva samples after standard premedication with paracetamol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johanna Kujala

Investigators

  • Principal Investigator: Eija Kalso, University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 4, 2024

Study Completion (Estimated)

March 4, 2024

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FEPODPara2021-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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