NCT03513822

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

Ketamine's Efficiency in the Treatment of Chronic Pain With an Added Inflammatory Component Exploring the Kynurenin Pathway. A Randomized, Double Blind, Placebo-controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Redar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Population Adult, medullary injured (BM), with chronic neuropathic pain (DN). 4 groups: BM with DN with bedsore Ketamine Group versus Placebo Group BM with DN without bedsore group Ketamine versus Placebo Group Intervention Ketamine infusion 1 mg / kg IVSE over two hours versus Nacl perfusion 0.9%  Primary judgment criterion Decrease by more than 30% the intensity of neuropathic pain evaluated at the moment on a numerical scale of 10 points between H0 and H4. Comparison of groups two by two. Secondary judgment criterions: NPSI score (Neuropathic pain symptom inventory) at H1, H4, D1, D4, J7 Sub score of NPSI; H1, H4, J1, J4, J7 Depression Scale HADS (Hospital Anxiety Depression Scale) J0, J1, J7 Plasma serotonin (5-HT) kynurenine (KYN), indoleamine 2,3-dioxygenase 1 (IDO1) activity (KYN / TRP ratio), kynurenic acid ( KA) and quinolinic acid (QA), as well as 3 proinflammatory cytokines IL-1β, IL-6, and TNF-α before perfusion and H4 perfusion. In parallel blood samples will be collected to study the activation of the kynurenine pathway in response to inflammation due to a pressure ulcer.

Conditions

• Neuralgia
• Chronic Pain
• Inflammation

Interventions

Type	Name	Description
DRUG	Ketamine 10 MG/ML	Ketamine infusion 1mg/kg with electric syringe during 2 hours.
DRUG	Placebos	Sodium chloride infusion with the same rate, electric syringe during 2 hours.
DRUG	Midazolam 1 MG/ML	Bolus of Midazolam 1mg before each perfusion.

Timeline

• Start date: 2018-02-16
• Primary completion: 2018-10-01
• Completion: 2018-11-01
• First posted: 2018-05-02
• Last updated: 2018-05-02

Locations

1 site across 1 country: France