How paracetamol and cefazolin behave in normal-weight and overweight children
Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children
This study will test how paracetamol and cefazolin move through the body in children aged 2–15 who are normal weight or overweight during minor elective surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 2 Years to 15 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT07585487 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll children aged 2 to 15 admitted for minor elective surgery who will receive paracetamol and/or cefazolin as part of routine care. Multiple blood samples and adipose tissue fluid samples will be collected during the perioperative period to measure paracetamol concentrations in blood and cefazolin concentrations in plasma and subcutaneous adipose tissue. Pharmacokinetic parameters and concentration–time profiles will be derived and compared between normal-weight and overweight participants. The goal is to characterize differences in drug exposure and tissue penetration that could affect dosing in these groups.
Who should consider this trial
Good fit: Children aged 2–15 undergoing minor elective surgery at Ghent University Hospital who will receive paracetamol and/or cefazolin and have intra-arterial or intravenous access for sampling are ideal candidates.
Not a fit: Children who are pregnant, have bleeding disorders or coagulopathy, lack vascular access, or whose parents do not consent are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the results could help tailor paracetamol and cefazolin dosing for overweight children to improve efficacy and reduce the risk of under- or overdosing.
How similar studies have performed: Pharmacokinetic studies of paracetamol and cefazolin in children exist, but direct comparisons of plasma and adipose tissue penetration between normal-weight and overweight pediatric patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ghent
- Ghent University Hospital, Ghent — Ghent, Belgium (Recruiting)
Study contacts
- Study coordinator: Pieter De Cock, Prof. Apr
- Email: pieter.decock@uzgent.be
- Phone: +32 9 332 29 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.