Observational Study of Ketamine Infusions for the Treatment of Chronic Pain

• Conditions: Chronic Pain
• Interventions: Drug: Ketamine

• Registration Number: NCT05477004
• Lead Sponsor: Theresa Lii

Brief Summary

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

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 Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Status Verified: 2024-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-19
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open label ketamine	Ketamine	Patients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care

Primary Outcome Measures

Name	Time	Method
Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale	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."

Secondary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States