Clinical trial NCT05477004: Observational Study of Ketamine Infusions for the Treatment of Chronic Pain
Official title: Ketamine Infusion for the Treatment Chronic Pain in Adults: a Prospective Observational Study to Characterize Predictors and Outcomes
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Pain
Keywords: ketamine
chronic pain
pain syndrome
neuropathic pain
complex regional pain syndrome
intractable pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale
timeFrame: 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:
measure: Change from baseline average pain intensity; measured with Numeric Rating Scale (NRS)
timeFrame: 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:
measure: Change from baseline opioid use; measured with 2 questions
timeFrame: 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: Change from baseline pain catastrophizing score; measured with Pain Catastrophizing Scale - Short Form
timeFrame: 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: Change from baseline pain interference score; measured with PROMIS Pain Interference
timeFrame: 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: Change from baseline physical function score; measured with PROMIS Physical Function
timeFrame: 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: Change from baseline depression score; measured with PROMIS Depression
timeFrame: 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: Change from baseline anxiety score; measured with PROMIS Anxiety
timeFrame: 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: Change from baseline sleep disturbance score; measured with PROMIS Sleep Disturbance
timeFrame: 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: Change from baseline global health score; measured with PROMIS Global Health
timeFrame: 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: Change from baseline body areas affected by pain; measured with CHOIR Body Map
timeFrame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Theresa Lii, MD
role: PRINCIPAL_INVESTIGATOR
References: