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

Inclusion Criteria6

  • 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 Criteria6

  • 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

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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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