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NCT05167591 Clinical Trial

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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05167591
Other study ID # FEPODPara2021-1
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date March 4, 2024

Study information
Verified date March 2024
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 4, 2024
Est. primary completion date March 4, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Drug concentration measurement
Measurement of paracetamol concentration in capillary, venous plasma and saliva samples after standard premedication with paracetamol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Johanna Kujala

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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