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Ketamine and Neuropathic Pain (KETAPAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02467517
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : June 10, 2015
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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. - 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. - To study the evolution time of pain and analgesia after the intravenous administration of ketamine and placebo,
  3. - To study the correlation of the analgesic response to administered products respectively ketamine, ketamine and magnesium sulfate, placebo.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Ketamine Drug: Magnesium Sulfate Drug: placebo : sodium chloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ketamine and Neuropathic Pain
Study Start Date : November 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: INTRAVENOUS KETAMINE Drug: Ketamine
Drug: Magnesium Sulfate
Drug: placebo : sodium chloride



Primary Outcome Measures :
  1. Numerical rating scale (NRS) [ Time Frame: at day 1 and for a period of 5 weeks (35 days). ]

Secondary Outcome Measures :
  1. Intensity of the average [ Time Frame: at day 1 ]
    Intensity of the average daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet

  2. Intensity of maximum daily pain [ Time Frame: at day 1 ]
    Intensity of maximum daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet,

  3. Impact on quality of life [ Time Frame: at day 1 ]
    Impact on quality of life, mood and sleep assessed by questionnaires.

  4. Impact on mood [ Time Frame: at day 1 ]
    Impact on quality of life, mood and sleep assessed by questionnaires.

  5. Impact on sleep [ Time Frame: at day 1 ]
    Impact on quality of life, mood and sleep assessed by questionnaires.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467517


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sub-Investigator: Noémie DELAGE         
Sub-Investigator: Pascale PICARD         
Sub-Investigator: Fabienne MARCAILLOU         
Sub-Investigator: Claude DUBRAY         
Sub-Investigator: Christian DUALE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02467517    
Other Study ID Numbers: CHU-0235
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Clermont-Ferrand:
Neuropathic pain
Ketamine
Magnesium sulfate
Quality of life
Anxiety and depression
Mood and sleep
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Magnesium Sulfate
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents