Ketamine and Midazolam Infusions for CRPS: Feasibility Study

NCT05945147 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 66661
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Complex Regional Pain Syndromes

Keywords

Feasibility Study; Ketamine; Midazolam; Complex Regional Pain Syndrome; Active Placebo; Analgesics; Dissociative Anesthetics; Chronic Pain; Neuropathic Pain

Outcome Measures

Primary Outcomes (7)

• Number and proportion of patients who can undergo the steps of recruitment, informed consent, enrollment, and randomization

  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.

  2 months after the study opens for enrollment

• Number and proportion of randomized participants who remain in the study until the last follow-up timepoint

  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.

  8 weeks after receiving intervention

• Change in participant masking

  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%.

  Daily during intervention administration (5 days), and once at 8 weeks after receiving intervention

• Change in participant masking

  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%.

  During intervention administration

• Change in investigator masking

  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%.

  8 weeks after receiving intervention

• Change in investigator masking

  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%.

  During intervention administration

• Number and types of adverse events

  Adverse events will be elicited from the participant in a brief, open-ended structured interview.

  8 weeks after receiving intervention

Secondary Outcomes (12)

• Pain intensity

  Baseline, daily during treatment (5 days), and daily for 8 weeks after treatment

• Treatment expectancies

  Baseline, and daily during treatment (5 days)

• Pain interference

  Baseline, and weekly for 8 weeks after the end of treatment

• Physical function

  Baseline, and weekly for 8 weeks after the end of treatment

• Depression (PROMIS)

  Baseline, and weekly for 8 weeks after the end of treatment

Study Arms (2)

Ketamine and Midazolam

EXPERIMENTAL

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

Drug: Ketamine; Drug: Midazolam

Midazolam and Saline

PLACEBO COMPARATOR

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

Drug: Midazolam; Drug: Normal Saline

Interventions

Ketamine 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

Also known as: Ketalar

Ketamine and Midazolam

Midazolam DRUG

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

Also known as: Versed

Ketamine and Midazolam; Midazolam and Saline

Normal Saline 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

Also known as: 0.9% Sodium Chloride

Midazolam and Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Chronic Pain; Neuralgia

Interventions

Ketamine; Midazolam; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Theresa R Lii, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 14, 2023
• Study Start (Estimated): January 1, 2099
• Primary Completion (Estimated): April 30, 2099
• Study Completion (Estimated): May 31, 2099
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)