Treatment of Complex Regional Pain Syndrome type I: A randomised, double-blind, placebo-controlled study with multiple rounds of S(+)-ketamine infusions - KetKetStudy

• Conditions: Chronic CRPS ian

• Registration Number: EUCTR2008-003693-17-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients are diagnosed with CRPS-1 according to the IASP-criteria;
• Patients must report a NRS spontaneous pain score of 5 or higher;
• The age of the patient is between 18 and 70 years;
• Patients must give a written informed consent;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients who are not able to give informed consent;
• Patients suffering from other syndromes/diseases interfering with pain ratings;
• Patients who have had previous ketamine continuous infusion;
• Patients with co-morbidity such as: kidney disease, severe liver disease, nerve damage in the
affected area, increased intracranial pressure, infectious disease, epilepsy, a psychiatric
illness, thyroid disease, cancer, cardiac disease, pulmonary disease, severe or uncontrolled
hypertension, aneurysm, glaucoma, history of cerebral vascular accident (CVA) < 1 year;
• Patients who are pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To massess the effect of multiple infusions of ketamine in pain from CRPS type 1;Secondary Objective: ;Primary end point(s): Primary aim<br>The primary aim of this study is to evaluate the effect of two consecutive infusions of S(+)-ketamine in patients with CRPS-I on pain relief. The design of the study is prospective, randomised, double-blind and placebo-controlled.<br>