Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Some key questions this study would like to answer:
STUDY PROCEDURES SUMMARY
Upon consenting to the study, eligible participants will be asked to share their contact information, some background health information, details about their scheduled infusion, prior ketamine experience, and baseline symptoms. All personal information will be kept private and secure. Participants will be assigned a unique study number, and their name and contact details will not be shared with anyone outside the core study team.
Afterwards, participants will:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Treated Cohort | Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain |
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine (Ketalar) | Drug | Intravenous ketamine infusion delivered as part of routine clinical care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in PROMIS Pain Interference Score From Baseline | From enrollment to 16 weeks after the ketamine infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Opioid Use From Baseline, Patient-Rated Global Assessment | From enrollment to 16 weeks after the ketamine infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults who have had a treating physician order ketamine infusion therapy for the treatment of chronic pain
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Protocol Director | Contact | 650-264-9442 | tlii@stanford.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | United States |
Not provided
Upon publication of study results with no end date
A proposal that describes planned analyses must be approved and a data sharing agreement must be signed before accessing IPD from the study team
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in PROMIS Sleep Disturbance Score From Baseline | From enrollment to 16 weeks after the ketamine infusion |
| Change in PROMIS Anxiety Score From Baseline | From enrollment to 16 weeks after the ketamine infusion |
| Change in PROMIS Depression Score From Baseline | From enrollment to 16 weeks after the ketamine infusion |
| Change in PROMIS Social Isolation Score From Baseline | From enrollment to 16 weeks after the ketamine infusion |
| Change in Pain Catastrophizing Scale Score From Baseline | From enrollment to 16 weeks after the ketamine infusion |
| Change in Pain Self-Efficacy Questionnaire Score From Baseline | From enrollment to 16 weeks after the ketamine infusion |
| Baseline Pain Medication Beliefs | From the medication subscale of the Survey of Pain Attitudes (SOPA-Med) Scale | Pre-Treatment Baseline |
| Average Drug Liking and Craving Score | Drug Liking and Craving Questionnaire items modified for ketamine | From 1 to 16 weeks after the ketamine infusion |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |