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NCT Number: NCT07585487

Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children

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.

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Key information

Conditions

Paracetamol Body Weight Cefazolin Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital, Ghent

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Anca Amza

CONTACT

[email protected]

+32 9 332 18 83

Pieter De Cock, Prof. Apr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin

Drug

Prophylactic Cefazolin treatment per standard-of-care

Other names: Cephazolin

Paracetamol (drug)

Drug

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

Other names: Acetaminophen

Primary outcomes

  1. Blood concentrations of paracetamol and its metabolites

    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 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).

  2. Cefazolin plasma and tissue concentrations

    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)

    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.

Secondary outcomes

  1. Biomarkers values: enzymes

    Time frame: 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).

  2. Biomarker values: proteins

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Annemie Bauters, MD.

CONTACT

[email protected]

+ 32 9 332 18 83

Pieter De Cock, Prof. Apr

CONTACT

[email protected]

+32 9 332 29 69

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: TISSUE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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