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Ketamine and Midazolam Infusions for CRPS: Feasibility Study

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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Withdrawn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

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

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

Trial contacts and locations

1

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Central trial contact

Theresa R Lii, MD, MS

Data sourced from clinicaltrials.gov

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