NL-OMON31841
Withdrawn
Phase 4
Treatment of Complex Regional Pain Syndrome type I;A randomised, double-blind, placebo-controlled study with multiple rounds of S(+)-ketamine infusions (The Ket Ket Study) - KetKet Study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 30
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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;
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.
Outcomes
Primary Outcomes
Not specified
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