Actively Recruiting

Age: 2Years - 15Years
All Genders
NCT07585487

Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children

Led by University Hospital, Ghent · Updated on 2026-05-13

120

Participants Needed

1

Research Sites

162 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pharmacokinetic evaluations will be conducted to characterize the cefazolin plasma concentration-time profile, cefazolin penetration into subcutaneous adipose tissue, and paracetamol metabolization as assessed through blood sampling. The study population consists of children aged 2 to 15 years with either normal weight or overweight. All participants are admitted for a minor elective surgical procedure and will receive paracetamol and/or cefazolin as part of standard perioperative care. During the procedure, multiple blood and tissue-fluid samples will be collected to quantify paracetamol and cefazolin concentrations in the bloodstream, as well as cefazolin concentrations in subcutaneous adipose tissue. The study aims to characterize drug concentration-time profiles in blood (paracetamol), plasma (cefazolin), and adipose tissue (cefazolin), and to compare these pharmacokinetic parameters between normal-weight and overweight children. These data are essential to determine whether standard dosing regimens provide adequate drug exposure across different weight categories. Previous research indicates that achieving specific target concentrations in blood and tissue is necessary for optimal therapeutic effect, yet uncertainty remains regarding appropriate dosing in overweight children.

CONDITIONS

Official Title

Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children

Who Can Participate

Age: 2Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient admitted to the operating room for minor elective surgery
  • Patients undergoing general anesthesia for minor elective surgery
  • Patient age: children from 2 years to 15 years
  • Patients receiving cefazolin or paracetamol according to the standard procedure
  • Intra-arterial (preferred) or intravenous access available for blood sampling
  • BMI
Not Eligible

You will not qualify if you...

  • Personal or family history of excessive bleeding
  • Pre-existing coagulopathy and/or thrombocytopenia
  • No catheter available for blood sampling
  • Absence of parental consent
  • Known allergy to one of the components of the study
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ghent University Hospital, Ghent

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

P

Pieter De Cock, Prof. Apr

CONTACT

A

Annemie Bauters, MD.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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