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Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children

NCT07585487 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Paracetamol
  • Cefazolin

Interventions

DRUG

Cefazolin

Prophylactic Cefazolin treatment per standard-of-care

DRUG

Paracetamol (drug)

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

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Anca Amza · Ghent University Hospital and Ghent Univeristy

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-22
Primary Completion
2027-01-30
Completion
2027-01-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585487 on ClinicalTrials.gov