RecruitingNCT07585487

Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children


Sponsor

University Hospital, Ghent

Enrollment

120 participants

Start Date

Dec 22, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cefazolin and Paracetamol (drug) for people with cefazolin and paracetamol. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCefazolin

Prophylactic Cefazolin treatment per standard-of-care

DRUGParacetamol (drug)

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


Locations(1)

Ghent University Hospital, Ghent

Ghent, Belgium

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NCT07585487


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