Clinical trial

Long-term Pain Modulation by Intravenous Esketamine in Complex Regional Pain Syndrome: a Non-inferiority Study

Name

NL77785.078.21

Description

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 6 months after the start of the study/treatment.

Trial arms

Trial start

2022-04-19

Estimated PCD

2026-10-01

Trial end

2027-10-01

Treatment

S-ketamine infusion inpatient setting

S-ketamine is administered intravenously for six consecutive days. The administered dose of S-ketamine is 50 mcg/kg/h and can be increased to a maximum of 200 mcg/kg/h.

Arms:

Inpatient

Other names:

ketamine, esketamine

S-ketamine infusion outpatient setting

S-ketamine is administered intravenously for six hours. The administered dose of S-ketamine is 50 mcg/kg/h and can be increased to a maximum of 200 mcg/kg/h.

Arms:

Outpatient

Other names:

ketamine, esketamine

Size

Primary endpoint

Change from baseline pain scores

Baseline (week 0), During inpatient or outpatient esketamine infusion (week 1 for inpatient protocol / week 1, 3, 5, 7, 9, 11 for outpatient protocol), During telephone consultation (week 1, 3, 5, 7, 9, 11), Follow-up (3 months), End of study (6 months)

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized non-inferiority study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-09-11

1 organization

2 products

1 indication

Organization

Erasmus Medical Center

Product

S-ketamine

Indication

Complex Regional Pain Syndromes

Product

S-ketamine infusion