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

NCT00579085 | Completed Phase 2 DMC

• 1 other identifier: 16078-2-1 version 2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The purpose of this study is to evaluate intravenous outpatient infusion of sub-anesthetic doses of ketamine for the treatment of CRPS by a 30% pain reduction post treatment

  Patients will be evaluated for three months after treatment

Secondary Outcomes (1)

• Lenght of relief of pain

  When and if pain returns to pre treatment levels

Study Arms (2)

1

PLACEBO COMPARATOR

Other: IV NSS; Other: Normal Saline

2

EXPERIMENTAL

INFUSION PLAN: All patients will be infused intravenously with 100 ml of normal saline with or without ketamine for four hours (25 ml/hr) daily for 10 days. The maximum intravenous ketamine infusion dose for this study will be 0.35 mg/kg/hr, not to exceed 25 mg/hr (100 mg of ketamine over a 4 hour period). On the first day, the intravenous ketamine infusion will be set to 50% of the maximum rate. On the second day, the intravenous ketamine infusion will be increased to 75% of the maximum rate. On the third day, the intravenous ketamine infusion will be increased to the maximum rate. The daily ketamine infusion rate is maintained at this level for the duration of the ten day study.

Drug: Ketamine

Interventions

Ketamine DRUG

IV Ketamine .35mg/kg times ten days.

2

IV NSS OTHER

Placebo inactive ingredients

1

Normal Saline OTHER

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)

1

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with CRPS based on the modified IASP (International Association for the Study of Pain) research criteria (Harden RN and Bruehl SP
• Diagnostic Criteria: The Statistical Derivation of the Four Criterion Factors.
• In CRPS: Current Diagnosis and Therapy, Progress in Pain Research and Management, Vol 32: pp 45-58, 2005), whose condition is intractable for at least six months and have failed at least three of the following therapies:
• Nerve blocks
• Opioid analgesics
• Non-opioid analgesics
• Non-steroidal anti-inflammatory drugs
• Anti-seizure medications
• Antidepressants
• Muscle relaxants; or
• Physical therapy.
• The patients must be ketamine naïve and can be of either gender including all racial and minority groups. The patient's age must be between 18 and 65 years, inclusive.
• The study subjects must report pain levels equal to or greater than 4 on a scale of 0-10 (0 = no pain and 10 = unbearable pain). The pain must be stable over time and not vary more that 1 pain level.
• The patient must be on a stable dose of CRPS medications for 28 days prior to and throughout the duration of the study.
• The patient must be accompanied by a responsible adult.

You may not qualify if:

• Patients less than 18 years of age will be excluded. In this initial study, patients over 65 years of age will be excluded due to possible unforeseen concomitant medical problem.
• Patients that have previously undergone intravenous ketamine infusions will be excluded from the study.
• Patients who are pregnant, are lactating, have known psychotic or psychiatric illness, are afflicted with glaucoma or have thyrotoxicosis will also be excluded.
• Any patient that is unable to provide consent due to cognitive difficulties will not be used in this study.
• Patients that can not provide the means to be transported home following daily infusions will be excluded from the study.
• The investigators feel that issues concerning monetary gain and or loss due to the patient's medical condition may adversely affect the study, therefore, patients with active litigation, compensation or disability issues related to their CRPS will be excluded.
• Patients with a history of substance abuse will be excluded.
• Patients on certain blood pressure lowering medications such as calcium blockers, or beta blockers will be excluded from the study.
• Patients with major medical problems including but not limited to; uncontrolled hypertension, hypotension, cardiac failure, renal failure or liver failure will not be used in this study.

Sponsors & Collaborators

• Drexel University College of Medicine: lead

Study Sites (1)

Drexel University College of Medicine Department of Neurology

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

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

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 21, 2007
• Study Start: September 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2009
• Last Updated: June 17, 2010

Record last verified: 2010-06

Locations

US (1)