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RECRUITING
NCT07585487

Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

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

Interventions

DRUG

Cefazolin

Prophylactic Cefazolin treatment per standard-of-care

DRUG

Paracetamol (drug)

Preoperative dose of paracetamol, as per standard-of-care

Locations (1)

Ghent University Hospital, Ghent

Ghent, Belgium