Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS - Full Text View

Sponsor:	Drexel University College of Medicine
Information provided by:	Drexel University
ClinicalTrials.gov Identifier:	NCT00579085

Purpose

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.

Condition	Intervention	Phase
Complex Regional Pain Syndrome	Drug: Ketamine Other: IV NSS Other: Normal Saline	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS

Resource links provided by NLM:

MedlinePlus related topics: Complex Regional Pain Syndrome

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Drexel University:

Primary Outcome Measures:

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 [ Time Frame: Patients will be evaluated for three months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lenght of relief of pain [ Time Frame: When and if pain returns to pre treatment levels ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2006
Study Completion Date:	November 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1	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)
Experimental: 2 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 IV Ketamine .35mg/kg times ten days.

Arms

Assigned Interventions

Placebo Comparator: 1

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)

Experimental: 2

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

IV Ketamine .35mg/kg times ten days.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
The patient will be instructed that he/she will not be allowed to drive home following the infusion. Therefore in order to be included in the study the subjects must arrange for transportation for the 10 day duration of the study.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579085

Locations

United States, Pennsylvania
Drexel University College of Medicine Department of Neurology
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Drexel University College of Medicine

More Information

No publications provided

Responsible Party:	Dr. Robert J. Schwartzman MD, Drexel University College of Medicine
ClinicalTrials.gov Identifier:	NCT00579085 History of Changes
Other Study ID Numbers:	16078-2-1 version 2
Study First Received:	December 20, 2007
Last Updated:	June 15, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012