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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label ketamine | Patients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | A multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline opioid use; measured with 2 questions | Question 1: Participants are asked whether they have used any opioid medications since their last ketamine infusion (yes/no). Question 2: Participants are asked to rate how their opioid use has changed on a 4-point scale ranging from "I have not used any opioids since my last ketamine infusion" to "I am using more opioids after my last ketamine infusion." |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Lii, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
Individual participant data that underlie the results reported in the publication, after deidentification (text, tables, figures, and appendices).
Immediately following publication. No end date.
IPD may be shared upon reasonable request to researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D013001 | Somatoform Disorders |
| D009437 | Neuralgia |
| D020918 | Complex Regional Pain Syndromes |
| D010148 | Pain, Intractable |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| 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 | Pain Catastrophizing Scale - Short Form is a 4-item scale with a total score ranging from 0-16, with higher scores indicative of more catastrophizing. | 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 | PROMIS Pain Interference is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more 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) |
| Change from baseline physical function score; measured with PROMIS Physical Function | PROMIS Physical Function is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of better physical function. | 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 depression score; measured with PROMIS Depression | PROMIS Depression is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more depression. | 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 anxiety score; measured with PROMIS Anxiety | PROMIS Anxiety is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more anxiety. | 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 sleep disturbance score; measured with PROMIS Sleep Disturbance | PROMIS Sleep Disturbance is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more sleep disturbance. | 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 global health score; measured with PROMIS Global Health | PROMIS Global Health is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of better overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. | 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 body areas affected by pain; measured with CHOIR Body Map | CHOIR Body Map is a validated self-report body map where participants select areas of the body affected by pain, with a higher number of selected areas indicative of more widespread pain. | 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion) |
| D001523 | Mental Disorders |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001342 | Autonomic Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |