Chronic PainNCT05477004
Observational Study of Ketamine Infusions for the Treatment of Chronic Pain
An observational study of Chronic Pain, run by Theresa Lii at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Has their ketamine infusion cancelled, which may occur before or after consenting to this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ketamine Infusion for the Treatment Chronic Pain in Adults: a Prospective Observational Study to Characterize Predictors and Outcomes
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Ketamine
- Keywords
- ketamine, chronic pain, pain syndrome, neuropathic pain, complex regional pain syndrome, intractable pain
- Medical subject headings
- Chronic Pain, Somatoform Disorders, Neuralgia, Complex Regional Pain Syndromes, Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
A multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting
| Study group | Role | What they receive |
|---|---|---|
| Open label ketamine | Patients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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 (1)
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.
Measured: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theresa Lii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theresa Lii, Stanford University
- Investigators
- Theresa Lii, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477004
- Sponsor's protocol ID
- 62561
- Status last verified
- Dec 2025
- First submitted
- 21 Jul 2022
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the publication, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Infusion for the Treatment Chronic Pain in Adults: a Prospective Observational Study to Characterize Predictors and Outcomes
- ClinicalTrials.gov ID
- NCT05477004
- Acronym / sponsor ID
- 62561
- Conditions
- Chronic Pain
- Keywords
- ketamine, chronic pain, pain syndrome, neuropathic pain, complex regional pain syndrome, intractable pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Theresa LiiUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label ketamine | – | Drug: KetaminePatients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Has their ketamine infusion cancelled, which may occur before or after consenting to this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: KetalarA multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting | Drug | Open label ketamine |
Primary outcome
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)
The PGIC Scale is a single-question 7-point Likert scale ranging from "Very much improved" to "Very much worse."
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the publication, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theresa Lii, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Theresa Lii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.