Observational Study of Ketamine Infusions for the Treatment of Chronic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ketamine Infusion for the Treatment Chronic Pain in Adults: a Prospective Observational Study to Characterize Predictors and Outcomes

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Has their ketamine infusion cancelled, which may occur before or after consenting to this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open label ketamine<br>Patients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care | Drug: Ketamine<br>* A multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting<br>* Other names: Ketalar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale | The PGIC Scale is a single-question 7-point Likert scale ranging from Very much improved to Very much worse. | 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline average pain intensity; measured with Numeric Rating Scale (NRS) | Participants rate their average pain intensity over the last 7 days using whole numbers on a 0-to-10 scale, with higher values indicative of more pain. | 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, chronic pain, pain syndrome, neuropathic pain, complex regional pain syndrome, intractable pain