Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS
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.
Complex Regional Pain Syndrome
Other: IV NSS
Other: Normal Saline
|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|
- 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 ]
- Lenght of relief of pain [ Time Frame: When and if pain returns to pre treatment levels ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 1||
Other: IV NSS
Placebo inactive ingredientsOther: Normal Saline
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)
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.
IV Ketamine .35mg/kg times ten days.
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