Clinical trial

Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children

Recruiting now · Not applicable · 1 countries · Registry ID NCT07585487

Recruiting nowNot applicableObservational

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age2 Years to 15 Years

SexAll

Healthy volunteersNot accepted

ConditionParacetamol, Cefazolin

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

Cefazolin

Drug

Prophylactic Cefazolin treatment per standard-of-care

Paracetamol (drug)

Drug

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

Primary outcomes

Blood concentrations of paracetamol and its metabolitesBlood VAMS samples collected at day0 (D0): 1) before infusion(D0): predose , 2) 5 minutes after infusion (D0), 3) 5-120 minutes after infusion (D0): distribution phase, 4) 2 hours after infusion (D0), 5) 3-5 hours after infusion (D0): elimination phase

Blood concentrations (mg/L) of paracetamol and its metabolites: glucuronide-, sulfate-, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol. Samples collected with Volumetric Absorptive Microsampling (VAMS).

Cefazolin plasma and tissue concentrationsAt D0 sampled: Plasma: 1) predose, 2) 5 minutes after infusion, 3) 5-120 minutes, 4) 2 hours, 5) 3-5 hours; Microdialysis: 1) baseline (-30 - 0 minutes), 2) first 2 hours after dosing (every 30 minutes a sample), 3) next 3 hours (every 1 hour a sample)

Plasma concentrations (mg/L) are stored in heparine blood tubes. Tissue concentrations (mg/L) are collected with a microdialysis device and stored in specific microdialysis vials.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ghent University Hospital, Ghent🇧🇪 Ghent, Belgium

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Anca AmzaContact

Email · Call +32 9 332 18 83

Pieter De Cock, Prof. Apr.Principal Investigator