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
This trial does not accept healthy volunteersQualifiers
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 population
Children undergoing minor elective surgery at Ghent University Hospital
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Cefazolin
DrugProphylactic Cefazolin treatment per standard-of-care
Paracetamol (drug)
DrugPreoperative dose of paracetamol, as per standard-of-care
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Standard of Care Paracetamol or Cefazolin treatment in children with normal weight2 interventions
Group B: Standard of Care Paracetamol or Cefazolin treatment in children with overweight2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
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 phase2
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.
Time frame
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
1
Biomarkers values: enzymes
Determination of the presence and concentration of enzymes based on the values Aspartate aminotransferase (AST; U/L), Alanine aminotransferase (ALT; U/L), and Gamma-Glutamyl transpeptidase (GGT; U/L).
Time frame
Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)2
Biomarker values: proteins
Determination of the presence and concentration of proteins based on the values Bilirubin (total \& direct; g/L), serum creatinine (SCR; g/L), total protein (g/L), Albumin (g/L), and C-reactive protein (CRP; g/L).
Time frame
Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)Sponsors and contacts
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Source ClinicalTrials.gov