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Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children
Sponsor: University Hospital, Ghent
Summary
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.
Key Details
Gender
All
Age Range
2 Years - 15 Years
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2023-12-22
Completion Date
2027-01-30
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
Cefazolin
Prophylactic Cefazolin treatment per standard-of-care
Paracetamol (drug)
Preoperative dose of paracetamol, as per standard-of-care
Locations (1)
Ghent University Hospital, Ghent
Ghent, Belgium