Esketamine via the bloodstream for Complex Regional Pain Syndrome

Phase 1

• Conditions: Complex Regional Pain Syndrome; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-000640-21-NL
• Lead Sponsor: Center for Pain Medicine, Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-03
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Age = 18 years.
-Meeting or having met the Budapest Criteria of CRPS (Harden, 2010)
-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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Inadequate comprehension of the Dutch language
-Pregnancy
-Unstable angina, poorly controlled hypertension, high-risk coronary vascular disease
-Severe liver disease
-Elevated intracranial pressure
-Elevated intraocular pressure, acute globe injury, or glaucoma
-Thyrotoxicosis
-Pheochromocytoma
-Active substance abuse
-Psychosis or delirium
-Refusal or inability to consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified