Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acetaminophen Serum Concentrations
研究概览
简要总结
This is a prospective study of pediatric patients with congenital heart disease, in which acetaminophen serum concentrations will be measured following a single intraoperative intravenous dose of acetaminophen. These levels will be used to develop a pharmacokinetic model. Serum concentrations will be compared between two groups of patients: (1) cyanotic patients presenting for the Fontan completion operation and (2) patients with acyanotic congenital heart disease presenting for repair via median sternotomy.
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 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting for Fontan palliation or for surgical repair requiring median sternotomy, will be included in the study.
- •Only patients who receive intravenous acetaminophen in the operating room will have serum levels drawn.
排除标准
- •Documentation of an allergy to acetaminophen
- •Severe hepatic disease or other contraindications to acetaminophen use
- •Patient has received acetaminophen within 24 hours of their procedure
研究组 & 干预措施
Cyanotic CHD
Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.
干预措施: Acetaminophen (Drug)
Acyanotic CHD
Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Acetaminophen Serum Concentrations
时间窗: 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration
The amount of acetaminophen in the blood stream at each time point after receiving a standard dose.
次要结局
未报告次要终点
研究者
Peter Winch
Associate Professor of Anesthesiology
Nationwide Children's Hospital