Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
