Clinical trial NCT05945147: Ketamine and Midazolam Infusions for CRPS: Feasibility Study
Official title: Feasibility Study Comparing a Ketamine and Midazolam Infusion to a Midazolam-Only Infusion for Complex Regional Pain Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Complex Regional Pain Syndromes
Keywords: Feasibility Study
Ketamine
Midazolam
Complex Regional Pain Syndrome
Active Placebo
Analgesics
Dissociative Anesthetics
Chronic Pain
Neuropathic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Assess whether the recruitment and retention rate observed in this feasibility study can support a larger clinical trial.
2. Evaluate whether participants can adhere to study procedures.
3. 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.
4. Gather preliminary data on clinically-relevant outcomes for CRPS.

Eligibility criteria: * Age 18 to 65 years
* Meets the International Association for the Study of Pain (IASP) diagnostic criteria for complex regional pain syndrome (CRPS)
* Primary complaint of CRPS-attributable pain for ≥3 months
* Average pain intensity of ≥3/10 over the last month
* Can read and comprehend English-language questionnaires
* Can receive text messages by phone
* Can identify a responsible adult who can provide transportation to and from infusion site for 5 consecutive days (Mon-Fri)

Primary outcomes:
measure: Number and proportion of patients who can undergo the steps of recruitment, informed consent, enrollment, and randomization
timeFrame: 2 months after the study opens for enrollment
measure: Number and proportion of randomized participants who remain in the study until the last follow-up timepoint
timeFrame: 8 weeks after receiving intervention
measure: Change in participant masking
timeFrame: Daily during intervention administration (5 days), and once at 8 weeks after receiving intervention
measure: Change in participant masking
timeFrame: During intervention administration
measure: Change in investigator masking
timeFrame: 8 weeks after receiving intervention
measure: Change in investigator masking
timeFrame: During intervention administration
measure: Number and types of adverse events
timeFrame: 8 weeks after receiving intervention
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline, daily during treatment (5 days), and daily for 8 weeks after treatment
measure: Treatment expectancies
timeFrame: Baseline, and daily during treatment (5 days)
measure: Pain interference
timeFrame: Baseline, and weekly for 8 weeks after the end of treatment
measure: Physical function
timeFrame: Baseline, and weekly for 8 weeks after the end of treatment
measure: Depression (PROMIS)
timeFrame: Baseline, and weekly for 8 weeks after the end of treatment
measure: Depression (PHQ-9)
timeFrame: Baseline, and weekly for 8 weeks after the end of treatment
measure: Anxiety
timeFrame: Baseline, and weekly for 8 weeks after the end of treatment
measure: Sleep disturbance
timeFrame: Baseline, and weekly for 8 weeks after the end of treatment
measure: Pain catastrophizing
timeFrame: Baseline, and weekly for 8 weeks after the end of treatment
measure: Chronic pain acceptance
timeFrame: Baseline, and weekly for 8 weeks after the end of treatment
measure: Patient global impression of change
timeFrame: Weekly for 8 weeks after the end of treatment
measure: Number of painful body regions
timeFrame: Baseline, and weekly for 8 weeks after the end of treatment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Theresa R Lii, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: