Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children

NCT07585487 | Recruiting

• 1 other identifier: ONZ-2023-0432
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Paracetamol; Cefazolin; Overweight; children

Outcome Measures

Primary Outcomes (2)

• Blood concentrations of paracetamol and its metabolites

  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).

  Blood 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

• Cefazolin plasma and tissue concentrations

  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.

  At 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)

Secondary Outcomes (2)

• Biomarkers values: enzymes

  Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)

• Biomarker values: proteins

  Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)

Study Arms (2)

Standard of Care Paracetamol or Cefazolin treatment in children with normal weight

Drug: Cefazolin; Drug: Paracetamol (drug)

Standard of Care Paracetamol or Cefazolin treatment in children with overweight

Drug: Cefazolin; Drug: Paracetamol (drug)

Interventions

Cefazolin DRUG

Prophylactic Cefazolin treatment per standard-of-care

Also known as: Cephazolin

Standard of Care Paracetamol or Cefazolin treatment in children with normal weight; Standard of Care Paracetamol or Cefazolin treatment in children with overweight

Paracetamol (drug) DRUG

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

Also known as: Acetaminophen

Standard of Care Paracetamol or Cefazolin treatment in children with normal weight; Standard of Care Paracetamol or Cefazolin treatment in children with overweight

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing minor elective surgery at Ghent University Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital, Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Overweight

Interventions

Cefazolin; Acetaminophen; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Anca Amza

  Ghent University Hospital and Ghent Univeristy

  STUDY DIRECTOR

Central Study Contacts

Pieter De Cock, Prof. Apr

CONTACT

+32 9 332 29 69; pieter.decock@uzgent.be

Annemie Bauters, MD.

CONTACT

+ 32 9 332 18 83; Annemie.Bauters@UGent.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: May 13, 2026
• Study Start: December 22, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

BE (1)