Ketamine and Neuropathic Pain

NCT02467517 | Unknown Phase 2

• 1 other identifier: CHU-0235
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The primary outcome is to compare the analgesic efficacy of intravenous ketamine treatment to that of a placebo in patients with refractory neuropathic pain. The secondary outcomes are:

1. 1.\- To compare the additive analgesic efficacy of prior administration of magnesium sulfate to that of placebo and ketamine only, on the effectiveness of intravenous ketamine treatment,
2. 2.\- To study the evolution time of pain and analgesia after the intravenous administration of ketamine and placebo,
3. 3.\- To study the correlation of the analgesic response to administered products respectively ketamine, ketamine and magnesium sulfate, placebo.

Conditions

Neuropathic Pain

Keywords

Neuropathic pain; Ketamine; Magnesium sulfate; Quality of life; Anxiety and depression; Mood and sleep

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale (NRS)

  at day 1 and for a period of 5 weeks (35 days).

Secondary Outcomes (5)

• Intensity of the average

  at day 1

• Intensity of maximum daily pain

  at day 1

• Impact on quality of life

  at day 1

• Impact on mood

  at day 1

• Impact on sleep

  at day 1

Study Arms (1)

INTRAVENOUS KETAMINE

EXPERIMENTAL

Drug: Ketamine; Drug: Magnesium Sulfate; Drug: placebo : sodium chloride

Interventions

Ketamine DRUG

INTRAVENOUS KETAMINE

Magnesium Sulfate DRUG

INTRAVENOUS KETAMINE

placebo : sodium chloride DRUG

INTRAVENOUS KETAMINE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (s) are at least18 years old, with chronic pain (for more than 3 months), having the characteristics of a peripheral or central neuropathy, follow (s) at the Pain Clinic CHU Clermont-Ferrand and justifying the establishment of a therapeutic program including intravenous infusion of ketamine (as therapeutic test);
• Patient (s) who had never received ketamine infusion under the care of their neuropathic pain;
• History of illness compatible with an injury or disease of the somatosensory system;
• Localized pain in an anatomical neuro territory;
• Neurological examination shows sensory abnormalities,
• The patients of childbearing potential must use effective contraception throughout the study;
• For womens of childbearing age, they will be enrolled in the study after a negative urine pregnancy test; in case of suspicion of pregnancy, a blood pregnancy test should be performed;
• Cooperation and willing to follow the study;
• Acceptance to give written consent;
• Affiliated to the French social security;
• Inscription or acceptation of inscription in the national register of volunteers involved in trials.

You may not qualify if:

• Patient (s) who have received intravenous ketamine infusion;
• Patients with one or many contraindication to ketamine administration: known hypersensitivity to ketamine in which one of the constituents of the product, uncontrolled high blood pressure, severe cardiac insufficiency;
• Patients with one or many contraindication of magnesium sulfate administration: Patients with severe renal impairment;
• Patients with one or many contraindication to administration of sodium chloride: water inflation, fluid retention;
• Patients with a medical history and / or surgical judged by the investigator to be not consistent with the clinical trial;
• Patients with drug treatments judged by the investigator to be not consistent with the clinical trial;
• Pregnancy or lactation women;
• Patients with cooperation and understanding not to adhere strictly to the conditions provided in the clinical trial;
• Patients receiving a measure of legal protection (guardianship…);
• Patients are not affiliated to the System of the French Social Security

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Neuralgia; Anxiety Disorders; Depression

Interventions

Ketamine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 10, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

FR (1)