Observational Study of Ketamine Infusions for the Treatment of Chronic Pain

NCT05477004 | Enrolling By Invitation FDA Drug

• 1 other identifier: 62561
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

ketamine; chronic pain; pain syndrome; neuropathic pain; complex regional pain syndrome; intractable pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Other Outcomes (9)

• Change from baseline opioid use; measured with 2 questions

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

• Change from baseline pain catastrophizing score; measured with Pain Catastrophizing Scale - Short Form

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

• Change from baseline pain interference score; measured with PROMIS Pain Interference

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

Study Arms (1)

Open label ketamine

Patients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care

Drug: Ketamine

Interventions

Ketamine DRUG

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

Also known as: Ketalar

Open label ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study population consists of adults who receive a ketamine infusion for the treatment of any chronic pain condition. All patients who are scheduled for a ketamine infusion through Stanford's Pain Management Center during this study's enrollment period are contacted for screening.

You may qualify if:

• 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.

You may not qualify if:

• Has their ketamine infusion cancelled, which may occur before or after consenting to this study.

Sponsors & Collaborators

• Theresa Lii: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Chronic Pain; Somatoform Disorders; Neuralgia; Complex Regional Pain Syndromes; Pain, Intractable

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Theresa Lii, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Scholar

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 27, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: IPD may be shared upon reasonable request to researchers who provide a methodologically sound proposal.

Locations

US (1)