Actively Recruiting
Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children
Led by University Hospital, Ghent · Updated on 2026-05-13
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to characterize how the drugs paracetamol and cefazolin behave in the bodies of children aged 2 to 15 years who have either normal weight or are overweight. The study focuses on children admitted for minor elective surgeries and investigates how these drugs are processed in the blood and subcutaneous fat tissue. The goal is to understand whether standard drug dosing provides proper exposure for children across different weight categories. Participants receive paracetamol and/or cefazolin as part of their usual perioperative care. During the surgical procedure, multiple blood and tissue-fluid samples are collected to measure drug concentrations over time. Sampling times include before and after drug infusion, covering distribution and elimination phases in blood and plasma, and cefazolin levels in adipose tissue using microdialysis. Throughout the study, blood samples will be analyzed for drug levels and metabolites, along with enzyme and protein biomarkers. The research team will compare pharmacokinetic profiles between normal-weight and overweight children to assess drug exposure. Participants are involved during their surgery and recovery, with detailed sampling timed at specific intervals. The total participation covers the day of surgery with no long-term follow-up specified.
CONDITIONS
Brief Title
Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 15 years
- Admitted for minor elective surgery
- Undergoing general anesthesia for minor elective surgery
- Receiving cefazolin or paracetamol as per standard care
- Intra-arterial or intravenous access available for blood sampling
- Body mass index (BMI) recorded
You will not qualify if you...
- Personal or family history of excessive bleeding
- Pre-existing coagulopathy or thrombocytopenia
- No catheter available for blood sampling
- Absence of parental consent
- Known allergy to any study component
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (single day)
Participants undergo blood and microdialysis sampling to measure paracetamol and cefazolin concentrations before and after drug administration during minor elective surgery.
1 day with multiple blood and tissue sampling timepoints
Duration - Up to several hours post administration on Day 0
Participants are observed following the standard-of-care administration of paracetamol or cefazolin during surgery, with biomarker measurements collected 2 hours after drug administration.
1 follow-up visit on Day 0
Trial Site Locations
Total: 1 location
1
Ghent University Hospital, Ghent
Ghent, Belgium, 9000
Actively Recruiting
Research Team
P
Pieter De Cock, Prof. Apr
A
Annemie Bauters, MD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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