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Ketamine Clinical Trials

Treatment of Complex Regional Pain Syndome type 1: a randomised, double-blind, placebo-controlled study with S(+)-ketamine.

To see complete record on www.trialregister.nl, please visit this link

Id: NTR507

Organisation Name: Leiden University Medical Center, dep. Anaesthesiology

Overal Status: Inclusion stopped, follow up

Start Date: 2005-12-01

Lead Sponsor: Leiden University Medical Center, dep. Anaesthesiology

Brief Summary: The treatment of Complex Regional Pain Syndrome type 1 (CRPS) is characterised by a trial and error approach. Until now no single mechanism in the natural course of CRPS is known that can be treated directly. In neuropathic pain studies ketamine (=NMDA receptor antagonist) in subanaesthetic doses has proven its efficacy. In few CRPS studies patients benefited from the treatment with ketamine i.v. However, these studies were not double-blind controlled. The present study is directed at the continuous intravenous administration of sub-anaesthetic doses of S(+)-ketamine on a clinical patient basis to evaluate the role of the NMDA receptor activation in the pathophysiology of CRPS (proof of concept study). For clinical interest an intent-to-treat analysis will be performed as well. Furthermore this study investigate the pharmacokinetics and pharmacodynamics of (S+)-ketamine in subanaesthetic doses.

Country: Netherlands