Observational Study of Ketamine Infusions for the Treatment of Chronic Pain

N/AEnrolling By InvitationNCT05477004

Theresa Lii100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Chronic Pain

Interventions

KetamineDRUG

A multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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."

Time frame: 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 Outcomes

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.

Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)

Data from ClinicalTrials.gov

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