Observational Study of Ketamine Infusions for the Treatment of Chronic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ketamine Infusion for the Treatment Chronic Pain in Adults: a Prospective Observational Study to Characterize Predictors and Outcomes
Overview
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.
Interventions
- Drug Ketamine
A multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting
Primary outcome measures
- Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale [Time frame: 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 outcome measures (1)
- Change from baseline average pain intensity; measured with Numeric Rating Scale (NRS) [Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT05477004 · 62561