Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children

Обзор

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.

Вмешательства

• Препарат Cefazolin
  Prophylactic Cefazolin treatment per standard-of-care
• Препарат Paracetamol (drug)
  Preoperative dose of paracetamol, as per standard-of-care

Первичные конечные точки

• Blood concentrations of paracetamol and its metabolites [Срок оценки: 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]
• Cefazolin plasma and tissue concentrations [Срок оценки: 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)]

Вторичные конечные точки (2)

• Biomarkers values: enzymes [Срок оценки: Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)]
• Biomarker values: proteins [Срок оценки: Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Бельгия · 1 центр

• Ghent University Hospital, Ghent — Ghent

Идентификаторы

NCT: NCT07585487 · ONZ-2023-0432

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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