Ketamine Infusion for the Treatment Chronic Pain in Adults: a Prospective Observational Study to Characterize Predictors and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale
研究概览
简要总结
This observational study will collect prospectively specified data on patient characteristics and clinically relevant outcomes in patients who receive a ketamine infusion at Stanford Pain Management Center for the treatment of chronic pain, with the goal of identifying treatment responders and relationships between patient characteristics and treatment response.
详细描述
Ketamine is a type of anesthetic drug which has been used off-label to treat chronic pain. The effectiveness of intravenous ketamine and its duration of effect are not well-understood. There is high variability in response to ketamine, and it remains unclear which patient characteristics are associated with favorable outcomes. This observational study will collect a wide range of patient-reported outcomes via digital surveys: once at baseline before treatment, and up to 7 follow-up surveys for up to 12 months following a single ketamine infusion. Survey data will be supplemented by clinical data obtained from electronic medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has been seen at Stanford's Pain Management Center for a doctor's visit at least once.
- •Is scheduled to undergo at least 1 ketamine infusion for the treatment of any chronic pain condition.
- •Have a valid email address and consents to receiving surveys by email.
- •Able to read, understand, and respond to English-language surveys on an electronic device such as a cell phone, tablet, or computer.
- •Able to read, understand, and provide written, dated informed consent.
排除标准
- •Has their ketamine infusion cancelled, which may occur before or after consenting to this study.
研究组 & 干预措施
Open label ketamine
Patients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care
干预措施: Ketamine (Drug)
结局指标
主要结局
Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale
时间窗: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
The PGIC Scale is a single-question 7-point Likert scale ranging from "Very much improved" to "Very much worse."
次要结局
- Change from baseline average pain intensity; measured with Numeric Rating Scale (NRS)(1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion))
研究者
Theresa Lii
Clinical Scholar
Stanford University