Paracetamol, Cefazolin
Conditions
Keywords
Paracetamol, Cefazolin, Overweight, children
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.
Interventions
DRUGCefazolin
Prophylactic Cefazolin treatment per standard-of-care
Preoperative dose of paracetamol, as per standard-of-care
Sponsors
University Hospital, Ghent
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cefazolin plasma and tissue concentrations | 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) | 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. |
| Blood concentrations of paracetamol and its metabolites | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers values: enzymes | Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0) | 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). |
| Biomarker values: proteins | Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0) | 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). |
Countries
Belgium
Contacts
CONTACTPieter De Cock, Prof. Apr
CONTACTAnnemie Bauters, MD.
STUDY_DIRECTORAnca Amza
Ghent University Hospital and Ghent Univeristy
Outcome results
None listed