Long-term Pain Modulation by Intravenous Esketamine in CRPS
Status:
Recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
Intravenous administration of esketamine is an effective recognized therapeutic option in
refractory pain in CRPS, which sometimes in at least a part of the patients has a prolonged
therapeutic effect. Unfortunately, CRPS literature contains a wide range of ketamine dosing
regimens with the result that clinical protocols on dosage and administration are very
heterogeneous. The current esketamine regimen in Erasmus MC consists of a 6-day hospital
admission for continuous administration. In the Netherlands, both inpatient and outpatient
esketamine treatments are offered. Inpatient and outpatient ketamine treatments have never
been compared in randomized controlled trials and it is therefore unknown whether these two
dosing regimens are equally effective.
The primary objective is to demonstrate non-inferiority of experimental esketamine
administration of 6x 1 day per 2 weeks (in total 3 months) as compared with standard
esketamine administration of 1x 6 consecutive days. The end of study is at 3 months after the
start of the study/treatment.