Ketamine and Midazolam Infusions for CRPS: Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2099-01-01

Study Completion Date

2099-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Complex Regional Pain Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

An escalating dose of ketamine (0.15 to 0.4 mg/kg/hr) will be administered as 4-hour infusions over 5 consecutive days

Midazolam

Intervention Type DRUG

A constant dose of midazolam (0.04 mg/kg/hr) will be administered as 4-hour infusions over 5 consecutive days

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.

Group Type PLACEBO_COMPARATOR

Midazolam

Intervention Type DRUG

A constant dose of midazolam (0.04 mg/kg/hr) will be administered as 4-hour infusions over 5 consecutive days

Normal Saline

Intervention Type DRUG

An escalating dose of normal saline (0.15 to 0.4 mg/kg/hr) will be administered as 4-hour infusions over 5 consecutive days

Interventions

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Ketamine

An escalating dose of ketamine (0.15 to 0.4 mg/kg/hr) will be administered as 4-hour infusions over 5 consecutive days

Intervention Type DRUG

Midazolam

A constant dose of midazolam (0.04 mg/kg/hr) will be administered as 4-hour infusions over 5 consecutive days

Intervention Type DRUG

Normal Saline

An escalating dose of normal saline (0.15 to 0.4 mg/kg/hr) will be administered as 4-hour infusions over 5 consecutive days

Intervention Type DRUG

Other Intervention Names

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Ketalar Versed 0.9% Sodium Chloride

Eligibility Criteria

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Inclusion 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No