Chronic pain patients: CRPS-1, fibromyalgia and neurptahic pain
Conditions
Interventions
Trade Name: Ketanest-S
Product Name: Ketanest-S
Product Code: RVG22550
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: KETAMINE
CAS Number: 6740881
Other descriptive name: Ketanest
Conc
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria. (i) Patients diagnosed with CRPS-1, small-fiber neuropathy or fibromyalgia, according to the guidelines of the IASP or other professional pain societies (eg., Netherlands Society of Anesthesiologists); (ii) a pain score of 5 or higher; (iii) age between 18 and 75 years; (iv) being able to give written informed consent. Volunteer inclusion criteria. Healthy volunteers in the age range 18-75 years of either sex. 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: Patient and volunteer exclusion criteria. (i) Unable to give written informed consent; (ii) medical disease such as renal, liver, cardiac, vascular (incl. hypertension) infectious disease; (iii) increased intracranial pressure; (iv) epilepsy; (v) psychosis; (vi) glaucoma; (vii) a history of cerebro-vascular accident 30).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the effect of S-ketamine on chronic pain;Secondary Objective: none;Primary end point(s): Pain relief in response to ketamine treatment as measured by OA and DNIC | — |
Countries
Netherlands
Outcome results
None listed