Hepatic Cytochrome Drug Interactions in Emergency Department Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
研究概览
简要总结
This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.
详细描述
Patients with pain and/or nausea are enrolled in the Emergency Department (ED). They are given either oxycodone, hydrocodone, or ondansetron at the discretion of the Emergency Department (ED) provider or the triage nurse by triage protocol. Detailed prescription, over the counter, herbal, supplement, and illicit drug ingestion histories are taken from the patient or their health care proxy. Serial visual analogue scales are captured prior to study drug administration then between 30 and 90 minutes following drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self-reported pain or nausea identified by the initial nursing assessment
排除标准
- •unable to speak English,
- •< 18 y.o.,
- •previously diagnosed with chronic pain or cyclic vomiting
研究组 & 干预措施
Oxycodone group
Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization.
干预措施: Oxycodone (Drug)
Nausea-observational group
Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only.
干预措施: Ondansetron (Drug)
Hydrocodone/Acetaminophen group
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
干预措施: Hydrocodone (Drug)
结局指标
主要结局
Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
时间窗: Baseline and 90 minutes
Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.
次要结局
- Adverse Drug Events(Duration of ED stay, <24 hours. (up to 24 hours))