Outcomes Registry After Ketamine Infusions for Chronic Pain: A Longitudinal Evaluation

NCT07648771 | Not Yet Recruiting FDA Drug

• 1 other identifier: 87368
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Ketamine is an anesthetic drug that is sometimes used to relieve chronic pain. The goal of this observational study is to learn about how patients respond to ketamine infusions for chronic pain. Note: This study does not provide ketamine - instead, this study uses surveys to follow patients who are already scheduled to receive ketamine infusions as part of their regular medical care. We will also follow a second group of patients who were recommended ketamine infusions by their doctor but were denied insurance coverage for this treatment. These participants will complete the same surveys for up to 16 weeks, starting from when their treatment was originally scheduled. Comparing this group to patients who received ketamine will help researchers better understand ketamine's effects and how insurance denials affect chronic pain patients.

Conditions

Chronic Pain; Ketamine

Keywords

Observational; Registry; Longitudinal; Surveys; Ketamine; Chronic Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Change in PROMIS Pain Interference Score From Baseline

  From enrollment to 16 weeks after the ketamine infusion

Secondary Outcomes (1)

• Change in Opioid Use From Baseline, Patient-Rated Global Assessment

  From enrollment to 16 weeks after the ketamine infusion

Other Outcomes (10)

• Change in Pain Intensity From Baseline, 0-10 Numeric Rating Scale

  From enrollment to 16 weeks after the ketamine infusion

• Change in PROMIS Physical Function Score From Baseline

  From enrollment to 16 weeks after the ketamine infusion

• Change in PROMIS Sleep Disturbance Score From Baseline

  From enrollment to 16 weeks after the ketamine infusion

Study Arms (2)

Ketamine Treated Cohort

Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain

Drug: Ketamine (Ketalar)

Denied Treatment Cohort

Observational cohort of patients who were recommended ketamine infusion therapy but did not receive this treatment due to lack of insurance coverage

Interventions

Ketamine (Ketalar) DRUG

Intravenous ketamine infusion delivered as part of routine clinical care

Also known as: Ketamine Infusion, Intravenous Ketamine

Ketamine Treated Cohort

Eligibility Criteria

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

Study Population

Adults who have had a treating physician order ketamine infusion therapy for the treatment of chronic pain

You may qualify if:

• Planning to receive an intravenous ketamine infusion for the treatment of chronic pain

You may not qualify if:

• Unable to read or understand English questionnaires

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Chronic Pain; Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Protocol Director

CONTACT

650-264-9442; tlii@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Upon publication of study results with no end date
• Access Criteria: A proposal that describes planned analyses must be approved and a data sharing agreement must be signed before accessing IPD from the study team

Locations

US (1)