Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-15
SponsorUniversity Hospital, Ghent

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Personal or family history of excessive bleeding

Pre-existing coagulopathy and/or thrombocytopenia

No catheter available for blood sampling

Absence of parental consent

Trial design

Treatments tested in this trial

  • Cefazolin
  • Paracetamol (drug)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators