Overview

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.