Determination of serum paracetamol concentration with an electrochemical measurement tool from blood and saliva samples in patients using also other medication.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000360-30-FI

Enrollment

Registered

2021-04-20

Start date

2021-05-03

Completion date

Unknown

Last updated

2024-03-18

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

Conditions

Patients with any medical condition that requires regular medication and who are undergoing elective surgery.

Interventions

Trade Name: Panadol Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-75 yrs At least one medical condition that requires regular medication (American Society of Anesthesiology (ASA) Classification 2-4) Elective surgery, planned premedication with paracetamol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Age under 18 or over 76 yrs. Pregnancy, lactation. Prisoner Alcohol abuse Liver disease that prevents use of paracetamol as premedication for surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: We have previously validated a novel electrochemical paracetamol concentration measurement sensor in vivo and in healthy volunteers. Other medication can possibly cause disturbance in electrochemical analysis. Objective of this trial is to validate this novel sensor in patients who use other, possibly confounding medication. ;Secondary Objective: Saliva is a promising matrix in paracetamol concentration measurement. We will find out if paracetamol concentration measurement in saliva is reliable compared to measurement in plasma in patients who use confounding medication. ;Primary end point(s): Paracetamol concentration measurement with novel electrochemical sensor, gold standard mass-spectrometry and/or standard photometric method. ;Timepoint(s) of evaluation of this end point: 0.5-4 h after administration of paracetamol.	—

Measure

Time frame

Main Objective: We have previously validated a novel electrochemical paracetamol concentration measurement sensor in vivo and in healthy volunteers. Other medication can possibly cause disturbance in electrochemical analysis. Objective of this trial is to validate this novel sensor in patients who use other, possibly confounding medication. ;Secondary Objective: Saliva is a promising matrix in paracetamol concentration measurement. We will find out if paracetamol concentration measurement in saliva is reliable compared to measurement in plasma in patients who use confounding medication. ;Primary end point(s): Paracetamol concentration measurement with novel electrochemical sensor, gold standard mass-spectrometry and/or standard photometric method. ;Timepoint(s) of evaluation of this end point: 0.5-4 h after administration of paracetamol.

—

Secondary

Measure	Time frame
Secondary end point(s): Paracetamol concentration measurement in saliva, compared to concentration measured in plasma. ;Timepoint(s) of evaluation of this end point: 0,5- 4h after administration of paracetamol	—

Countries

Finland

Contacts

Public ContactPain clinic

Helsinki University Hospital

johanna.kujala@helsinki.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026