Feasibility Study Comparing a Ketamine and Midazolam Infusion to a Midazolam-Only Infusion for Complex Regional Pain Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Stanford University
- Locations
- 1
- Primary Endpoint
- Change in investigator masking
Study Overview
Brief Summary
This study will assess the feasibility of administering ketamine plus midazolam or midazolam alone, when infused over 5 days in an outpatient setting, to adults with complex regional pain syndrome (CRPS).
Detailed Description
Subanesthetic ketamine infusions are a potentially impactful treatment for chronic refractory pain, but the acute psychoactive effects of ketamine complicate successful masking in randomized trials. Multi-day ketamine infusions have produced long-lasting, but not permanent, remission of symptoms in complex regional pain syndrome (CRPS), a chronic and often debilitating neuropathic pain condition that can affect one or more limbs. In this feasibility study, 4 adults with CRPS will be randomized to receive either ketamine and midazolam or midazolam-only, infused over 5 days in an outpatient setting. The objectives of this feasibility study are:
- Assess whether the recruitment and retention rate observed in this feasibility study can support a larger clinical trial.
- Evaluate whether participants can adhere to study procedures.
- Determine whether midazolam, when given alone as an intravenous (IV) infusion, can be used as an active placebo that is well-tolerated, practical, and believable compared to a ketamine plus midazolam infusion.
- Gather preliminary data on clinically-relevant outcomes for CRPS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ketamine and Midazolam
Participants will receive intravenous infusions of ketamine and midazolam for 4 hours each day, over 5 consecutive days, in an outpatient setting.
Intervention: Ketamine (Drug)
Ketamine and Midazolam
Participants will receive intravenous infusions of ketamine and midazolam for 4 hours each day, over 5 consecutive days, in an outpatient setting.
Intervention: Midazolam (Drug)
Midazolam and Saline
Participants will receive intravenous infusions of midazolam and normal saline for 4 hours each day, over 5 consecutive days, in an outpatient setting.
Intervention: Midazolam (Drug)
Midazolam and Saline
Participants will receive intravenous infusions of midazolam and normal saline for 4 hours each day, over 5 consecutive days, in an outpatient setting.
Intervention: Normal Saline (Drug)
Outcomes
Primary Outcomes
Change in investigator masking
Time Frame: During intervention administration
Investigators administering and monitoring the drug infusions will be asked to guess the participant's assigned treatment in a forced binary choice and to rate their level of confidence on a scale from 0 to 100%.
Number and proportion of patients who can undergo the steps of recruitment, informed consent, enrollment, and randomization
Time Frame: 2 months after the study opens for enrollment
Out of all patients identified as potentially eligible for the study based on chart review, we will measure the number and proportion who can undergo the steps of recruitment, informed consent, enrollment, and randomization during a 2-month period.
Number and types of adverse events
Time Frame: 8 weeks after receiving intervention
Adverse events will be elicited from the participant in a brief, open-ended structured interview.
Change in participant masking
Time Frame: During intervention administration
Participants will be asked to guess their assigned treatment in a forced binary choice and to rate their level of confidence on a scale from 0 to 100%.
Number and proportion of randomized participants who remain in the study until the last follow-up timepoint
Time Frame: 8 weeks after receiving intervention
Out of all patients who were randomized to a treatment group, we will measure the number and proportion who remain in the study until their last follow-up timepoint.
Secondary Outcomes
- Pain interference(Baseline, and weekly for 8 weeks after the end of treatment)
- Anxiety(Baseline, and weekly for 8 weeks after the end of treatment)
- Sleep disturbance(Baseline, and weekly for 8 weeks after the end of treatment)
- Pain catastrophizing(Baseline, and weekly for 8 weeks after the end of treatment)
- Pain intensity(Baseline, daily during treatment (5 days), and daily for 8 weeks after treatment)
- Number of painful body regions(Baseline, and weekly for 8 weeks after the end of treatment)
- Treatment expectancies(Baseline, and daily during treatment (5 days))
- Physical function(Baseline, and weekly for 8 weeks after the end of treatment)
- Depression (PHQ-9)(Baseline, and weekly for 8 weeks after the end of treatment)
- Depression (PROMIS)(Baseline, and weekly for 8 weeks after the end of treatment)
- Chronic pain acceptance(Baseline, and weekly for 8 weeks after the end of treatment)
- Patient global impression of change(Weekly for 8 weeks after the end of treatment)
Investigators
Theresa Lii
Principal Investigator
Stanford University