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Ketamine + Midazolam for Complex Regional Pain Syndrome

Phase 2
Waitlist Available
Led By Theresa R Lii, MD, MS
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets IASP diagnostic criteria for CRPS
Age 18 to 65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly for 8 weeks after the end of treatment
Awards & highlights

Study Summary

This trial will study if ketamine & midazolam help relieve CRPS when given over 5 days in an outpatient setting.

Who is the study for?
Adults aged 18-65 with Complex Regional Pain Syndrome (CRPS) who've had pain for at least 3 months, can understand English questionnaires, and have a reliable adult to provide transportation during the trial. They must not be part of any group specifically excluded by the study's criteria.Check my eligibility
What is being tested?
The study is testing if it's feasible to give adults with CRPS either ketamine plus midazolam or just midazolam alone over five days in an outpatient setting. The goal is to see how well patients tolerate these infusions and their effect on CRPS pain.See study design
What are the potential side effects?
Ketamine may cause changes in blood pressure, dizziness, nausea, perceptual disturbances (like hallucinations), and mood changes. Midazolam can lead to sleepiness, memory issues, and sometimes paradoxical reactions like anxiety or agitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Complex Regional Pain Syndrome.
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I am between 18 and 65 years old.
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I have had pain from CRPS for 3 months or more.
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My average pain level has been 3 or higher in the past month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and weekly for 8 weeks after the end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and weekly for 8 weeks after the end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in investigator masking
Change in participant masking
Number and proportion of patients who can undergo the steps of recruitment, informed consent, enrollment, and randomization
+2 more
Secondary outcome measures
Anxiety
Chronic pain acceptance
Depression (PHQ-9)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketamine and MidazolamExperimental Treatment2 Interventions
Participants will receive intravenous infusions of ketamine and midazolam for 4 hours each day, over 5 consecutive days, in an outpatient setting.
Group II: Midazolam and SalinePlacebo Group2 Interventions
Participants will receive intravenous infusions of midazolam and normal saline for 4 hours each day, over 5 consecutive days, in an outpatient setting.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090
Midazolam
2018
Completed Phase 4
~1910

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,350 Total Patients Enrolled
Theresa R Lii, MD, MSPrincipal InvestigatorStanford University

Media Library

Ketamine and Midazolam Infusions (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05945147 — Phase 2
Complex Regional Pain Syndrome Research Study Groups: Ketamine and Midazolam, Midazolam and Saline
Complex Regional Pain Syndrome Clinical Trial 2023: Ketamine and Midazolam Infusions Highlights & Side Effects. Trial Name: NCT05945147 — Phase 2
Ketamine and Midazolam Infusions (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05945147 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research accessible to individuals who are under the age of fifty?

"This clinical trial is accepting applicants between the age of majority and 65 years old."

Answered by AI

Who meets the criteria to participate in this clinical research?

"To be eligible for the trial, hopeful participants must have complex regional pain syndrome and conform to an age range of 18-65. Currently, 4 people will be accepted into this medical study."

Answered by AI

Are Ketamine and Midazolam considered safe according to the Food and Drug Administration?

"Although there is some evidence of safety, but no efficacy data yet to support its use, the assessment score assigned by our team at Power for Ketamine and Midazolam was a 2."

Answered by AI

What outcomes is this clinical experiment seeking to accomplish?

"This medical study will measure its primary outcome, participant retention rate for 2 months following enrollment. Secondary outcomes include pain intensity (assessed via a numerical scale from 0 to 10), Pain Interference according to the PROMIS short form (scored on a 5-point Likert Scale) and Physical Function as evaluated by the corresponding PROMIS Short Form."

Answered by AI

Are there any opportunities available for participation in this clinical experimentation?

"Based on the data published to clinicaltrials.gov, this trial is not presently enlisting patients. This research project was initially posted on August 1st 2023 and last revised July 11th 2023; however, there are 1444 other studies that are actively searching for participants at this time."

Answered by AI

Who else is applying?

What state do they live in?
South Dakota
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve been trying everything and still struggling immensely. I've tried multiple drugs and other therapies with no results.
PatientReceived no prior treatments
I have CRPS and have tried various treatments and unfortunately, I am still in pain daily. I have had CRPS for two years and am willing to try any trials and treatments to get better. I am 17 currently but will be 18 in August.
PatientReceived 2+ prior treatments
I was diagnosed with CRPS-2 in March 2021. Since then, I have been to 2 different pain management clinics and 2 different physical therapy facilities. I have been to Orthopedic Surgeons as well. With the pain meds provided being limited to the few that I am not allergic to, there are few that I could take, most of which increased my liver enzymes too much to continue to take, but still were in ineffective. I also have had all of the suggested injections, none of which lasted more than 4 days at a time, some no more than an hour afterwards. My first pain management clinic introduced me to the Ketamine Infusions, which served to be extremely helpful in managing my pain. However, that clinic was found to be fraudulent in their practices and use of Ketamine, which lead me to the other pain management, who told me since the injections didn't work, there wasn't anything else they could do for me. The VA, as I am 100% disabled, is willing to pay the bill for the infusions, but since the FDA has not yet approved Ketamine as pain management treatment, no facility will accept the VA payments for chronic pain, only mental illness. So, I am willing to do whatever I need to not only help myself, but others to help deal with the worse pain I have ever dealt with in my life.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Ketamine and Midazolam Infusions for CRPS: Feasibility Study
Theresa Lii 2024. "Ketamine and Midazolam Infusions for CRPS: Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05945147.
~0 spots leftby Apr 2024
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