Ketamine and Midazolam Infusions for CRPS: Feasibility Study

Stanford University

Status and phase: Withdrawn; Phase 2

Conditions: Complex Regional Pain Syndromes

Treatments: Drug: Midazolam; Drug: Ketamine; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05945147

66661

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Ketamine and Midazolam

Experimental group

Description:

Participants will receive intravenous infusions of ketamine and midazolam for 4 hours each day, over 5 consecutive days, in an outpatient setting.

Treatment:

Drug: Ketamine

Drug: Midazolam

Midazolam and Saline

Placebo Comparator group

Description:

Participants will receive intravenous infusions of midazolam and normal saline for 4 hours each day, over 5 consecutive days, in an outpatient setting.

Treatment:

Drug: Normal Saline

Drug: Midazolam