Long-term Pain Modulation by Intravenous Esketamine in CRPS

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Treatments: Esketamine; Ketamine

Criteria

Inclusion Criteria:

• Meeting the new International Association for the Study of Pain (IASP) diagnostic criteria for CRPS ("the Budapest Criteria) (Harden et al., 2010) or having met the new IASP diagnostic criteria of CRPS ("CRPS with Remission of Some features") (Goebel et al., 2021).

• Willing and capable to participate in the study.

• CRPS in one upper extremity and/or CRPS in one lower extremity

• Treatment in an elective setting.

• Adequate comprehension of the Dutch language

• Age ≥ 18 years

Exclusion Criteria:

• Severe liver disease

• Psychiatric (schizophrenia, psychosis, delirium, manic depression)

• Active substance abuse

• Intoxication with alcohol or other substances

• Poorly controlled hypertension

• Unstable angina

• High-risk coronary vascular disease

• Heart failure

• Elevated intracranial pressure

• Elevated intraocular pressure

• Thyrotoxicosis

• Pregnancy

• Combination with derivates of xanthines (theophylline) or ergometrine