Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 551
- 试验地点
- 18
- 主要终点
- Elimination rate constant (ke)
研究概览
简要总结
The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
详细描述
This is a research study to find out what the side effects are of certain drugs that are commonly used for pain and to put people to sleep for surgery. The researchers also want to know how the drug is broken down in the body. Participants will be given these drugs as they are prescribed by their regular doctor. As part of the participant's standard of care, doctors will perform tests, ask questions, review medical information and measure vital signs (heart rate, blood pressure, etc). The researchers will collect information that doctors have already written in the medical records. The research study team will collect blood from participants at certain time points depending on when the participant was first given the drug (up to 5 samples over the course of 10 to 48 hours). Examples of current and upcoming anesthetics and analgesics include, but are not limited to: ketorolac (Toradol), ketamine (Ketalar), oxycodone (OxyContin), and morphine (Kadian, MS Contin).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0 to <18 years of age at time of enrollment (must see applicable appendix for details as not all appendices enroll across the entire age range)
- •Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)
- •Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)
- •Receiving one or more drugs of interest (DOI) per local standard of care
- •Meeting DOI-specific inclusion criteria (See Appendices)
排除标准
- •Known pregnancy
- •Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)
- •Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
干预措施: Ketorolac Tromethamine (Drug)
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
干预措施: Hydromorphone (Drug)
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
干预措施: Ketamine (Drug)
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
干预措施: Oxycodone (Drug)
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
干预措施: Morphine (Drug)
结局指标
主要结局
Elimination rate constant (ke)
时间窗: up to 48 hrs post dose
Absorption rate constant (ka)
时间窗: up to 48 hrs post dose
Clearance (CL) or apparent oral clearance (CL/F)
时间窗: up to 48 hours post dose
Volume of distribution (V) or apparent oral volume of distribution (V/F)
时间窗: up to 48 hours post dose
Half-life (t1/2)
时间窗: up to 48 hrs post dose
Time to achieve maximum concentration (TMAX)
时间窗: up to 48 hrs post dose
Area under the curve (AUC)
时间窗: up to 48 hrs post dose
Maximum concentration (CMAX)
时间窗: up to 48 hrs post dose
次要结局
未报告次要终点
研究者
Chi Dang Hornik
Associate Professor of Pediatrics
Duke University