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Ketamine and Neuropathic Pain (KETAPAIN)

Primary Purpose

Neuropathic Pain

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ketamine
Magnesium Sulfate
placebo : sodium chloride
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic pain, Ketamine, Magnesium sulfate, Quality of life, Anxiety and depression, Mood and sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INTRAVENOUS KETAMINE

Arm Description

Outcomes

Primary Outcome Measures

Numerical rating scale (NRS)

Secondary Outcome Measures

Intensity of the average
Intensity of the average daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet
Intensity of maximum daily pain
Intensity of maximum daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet,
Impact on quality of life
Impact on quality of life, mood and sleep assessed by questionnaires.
Impact on mood
Impact on quality of life, mood and sleep assessed by questionnaires.
Impact on sleep
Impact on quality of life, mood and sleep assessed by questionnaires.

Full Information

First Posted
May 29, 2015
Last Updated
July 28, 2016
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02467517
Brief Title
Ketamine and Neuropathic Pain
Acronym
KETAPAIN
Official Title
Ketamine and Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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: - 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, - To study the evolution time of pain and analgesia after the intravenous administration of ketamine and placebo, - To study the correlation of the analgesic response to administered products respectively ketamine, ketamine and magnesium sulfate, placebo.
Detailed Description
Description of the study: Single-center clinical trial, controlled, randomized, double-blind, crossover design, against inactive placebo. Each patient will receive successively the 3 products (ketamine / placebo, ketamine / magnesium sulfate, placebo / placebo) follows a predeter randomization list, with a wash-out period between each administration. Visit 1 -Inclusion visit, signature of informed consent form, clinical examination and fill questionnaires. For women of childbearing age a pregnancy test will be performed.The pain will be measured by a numerical scale. The pain will be evaluated by scoring on a numerical scale. A booklet for monitoring analgesic concomitant medication and overall pain on a numerical scale will be given to the patient 14 days before the programmed infusion. Visit 2 : Period 1 Day 0 Clinical examination, return of booklet completed by patient and fill questionnaires. The pain will be evaluated by scoring on a numerical scale before and after the infusion. For women of childbearing age a pregnancy test will be performed. Treatment allocation period follows a predeter randomization list. At the end of the infusion, a booklet for monitoring will be given to patients for the following weeks in order to score their overall pain until the next study period. The output of the hospital patient (CPC / CETD) after each treatment will be authorized by the investigator. Wash-out period: 5 weeks. Phone call 1 (Day 1): Patients will be called by phone to collect adverse events and concomitant medications. If necessary, the patients should return to consult the CPC / CETD for a clinical examination. Patients will be called the week before their scheduled visit, if at that time their spontaneous pain is still low, according to the opinion of the investigator, the infusion visit will be shifted to allow the pain level back its basal level. Visit 3 : Period 2 : Day 36 +/- 3 days Same of period 1. Phone call 2 J 37 +/- 3 days: Same of phone call 1. Visit 4 : Period 3 : Day 72 +/- 3 days Same of period 1 Phone call 3 J 73 +/- 3 days: Same of phone call 1. Visit 5 : Day 108 +/- 3 days Clinical examination, return of booklet completed by patient and fill questionnaires. The pain will be evaluated by scoring on a numerical scale For women of childbearing age a pregnancy test will be performed. This visit is the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Neuropathic pain, Ketamine, Magnesium sulfate, Quality of life, Anxiety and depression, Mood and sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INTRAVENOUS KETAMINE
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Type
Drug
Intervention Name(s)
placebo : sodium chloride
Primary Outcome Measure Information:
Title
Numerical rating scale (NRS)
Time Frame
at day 1 and for a period of 5 weeks (35 days).
Secondary Outcome Measure Information:
Title
Intensity of the average
Description
Intensity of the average daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet
Time Frame
at day 1
Title
Intensity of maximum daily pain
Description
Intensity of maximum daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet,
Time Frame
at day 1
Title
Impact on quality of life
Description
Impact on quality of life, mood and sleep assessed by questionnaires.
Time Frame
at day 1
Title
Impact on mood
Description
Impact on quality of life, mood and sleep assessed by questionnaires.
Time Frame
at day 1
Title
Impact on sleep
Description
Impact on quality of life, mood and sleep assessed by questionnaires.
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle PICKERING
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Noémie DELAGE
First Name & Middle Initial & Last Name & Degree
Pascale PICARD
First Name & Middle Initial & Last Name & Degree
Fabienne MARCAILLOU
First Name & Middle Initial & Last Name & Degree
Claude DUBRAY
First Name & Middle Initial & Last Name & Degree
Christian DUALE

12. IPD Sharing Statement

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Ketamine and Neuropathic Pain

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