Chronic CRPS ian
Conditions
Interventions
Trade Name: Ketanest-S
Product Name: Ketanest-S
Product Code: RVG 22550
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of th
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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. | — |
Countries
Netherlands
Outcome results
None listed