Ketamine's Efficiency in the Treatment of Chronic Pain: Kynurenin Pathway

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of action involves an interaction on the kynurenine pathway.

Study design: Interventional randomized placebo-controlled clinical trial.

Main goals:

1. To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component.

2. Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Redar
• Collaborators: Fondation Apicil; Hopital Lariboisière; Hôpital Raymond Poincaré; Hospital Ambroise Paré Paris; Institut National de la Santé Et de la Recherche Médicale, France; Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
• Treatments: Ketamine; Midazolam

Criteria

Inclusion Criteria:

• Adults speaking and understanding French

• presenting chronic neuropathic pain as defined by IASP

• Painful intensity> or = to 6/10 during the week preceding the inclusion - Medullary lesion, whatever the origin (traumatic, degenerative, tumoral, postoperative), responsible for paraplegia in a chronic state.

• Able to give informed consent, after clear, fair and appropriate information

• Having given their consent by a written consent signature.

Exclusion Criteria:

• Hypersensitivity to ketamine or any of its components

• Participation in another interventional trial, or participation in another trial.

• Patient unable to give consent.

• Pregnancy or breastfeeding

• Refusal to sign the consent

• Cardiovascular diseases associated in particular with disorders of rhythm and severe cardiac insufficiency, coronary insufficiency, discovered on examination, on ECG or by biological balance or known. - unstabilized HTA> 180/100 mmHg

• Severe hepatic and / or renal hepatic insufficiency.