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Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS

NCT00579085 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-06-17

No results posted yet for this study

Summary

Complex Regional Pain Syndrome is a debilitating and extremely difficult to treat condition. There is a large body of evidence demonstrating the therapeutic value of N-methyl-D-aspartate (NMDA)-receptor antagonists in CRPS. The NMDA antagonist ketamine has been shown to be effective in the treatment of CRPS, resulting in complete remission of the disease in some patients. The purpose of this study is to evaluate intravenous outpatient infusion of sub-anesthetic doses of ketamine for the treatment of CRPS. A thorough evaluation of this procedure, providing information into the degree of relief and which of the constellation of RSD symptoms are best alleviated by this procedure would result in the optimization of this therapy for the treatment of CRPS.

Conditions

  • Complex Regional Pain Syndrome

Interventions

DRUG

Ketamine

IV Ketamine .35mg/kg times ten days.

OTHER

IV NSS

Placebo inactive ingredients

OTHER

Normal Saline

INFUSION PLAN: All patients will be infused intravenously with 100 ml of normal saline for four hours (25 ml/hr) daily for 10 days.Both patient arms will receive 2mg of Versed x two doses IV. They will also receive Clonidine (0.1 mg, po)

Sponsors & Collaborators

  • Drexel University College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-09-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00579085 on ClinicalTrials.gov