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OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN (OKAPI)

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ClinicalTrials.gov Identifier: NCT03319238
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
The aim of this study is to evaluate the safety of use, benefits and risks of repeated use of ketamine for each patient with chronic pain in different structures of pain management.

Condition or disease Intervention/treatment
Chronic Pain Other: ketamine

Detailed Description:
This is an observational, longitudinal and multicenter study about use of ketamine. Benefits are assessed with pain intensity, anxiety, depression, quality of life and global impression of change. Risks are also assessed with adverse event collection.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN
Actual Study Start Date : July 7, 2016
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Ketamine

Group/Cohort Intervention/treatment
Patient cohort
Neuropathic pain patient taking ketamine
Other: ketamine
The aim of this study is to evaluate the safety of use, benefits and risks of repeated use of ketamine for each patient with chronic pain in different structures of pain management.




Primary Outcome Measures :
  1. Descriptive analysis of benefit [ Time Frame: At baseline ]
    Benefits (pain release after ketamine use) will be assessed by the Pain by the Numerical Pain Rating Scale (NPRS): the scale ranges from 0 no pain to 10 maximal tolerable pain, and risks will be assessed by collecting the ketamine adverse events reported by the patient and by the physician.


Secondary Outcome Measures :
  1. Descriptive analysis of risk (by collecting adverse event) of ketamine use. [ Time Frame: At baseline ]
    Biological statements will be collected during the usual care of patients, if possible (ASAT, ALAT, total bilirubin, conjugate bilirubin, free bilirubin, gamma glutamyl transferase, alkaline phosphatase,…)

  2. Neuropathic Pain in 4 questions (DN4), [ Time Frame: At baseline ]
    The Neuropathic pain in 4 questions (DN4) at baseline only. DN4 is a clinical tool for the diagnosis of neuropathic pain. This questionnaire has four questions divided into 10 items related to the interview (ie, symptoms) and to the sensory examination (ie, signs). The investigator asks and examines the patient and notes a response "no" or "yes" for each item: "yes" is scored as "1" and "no" is scored as "0". The sum of scores gives the total score of the patient (/10). DN4 is considered as positive if the patient obtains a score of 4/10.

  3. Patient Global Impression of Change, the characteristics of pain (PGIC) [ Time Frame: At baseline ]
    The Patient Global Impression of Change is a scale of global perception of change ("Deterioration" or "Improvement") realized at each telephone call except for baseline. This scale is graduated from 1 = very strongly improved to 7 = very strongly aggravated

  4. Emotional status by Hospital Anxiety and Depression scale (HAD) [ Time Frame: At baseline ]
    The HAD scale is a self-administered questionnaire in 14 items completed by the patient. It is used to determine the levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Global score ranges from 0 to 42.

  5. Quality of life (Short Form 12 items Short Form survey) [ Time Frame: At baseline ]
    assessed by a quality of life questionnaire (Short Form 12 items Short Form survey (SF12)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic pain
Criteria

Inclusion Criteria:

  • Aged over 18 years
  • Patients with chronic pain (more than 6 months)
  • Patients with peripheral or central neuropathic pain, fibromyalgia, algoneurodystrophy

Exclusion Criteria:

  • Patient under 18 years of age,
  • Patient not requiring prescription of ketamine

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): NCT03319238


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

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sub-Investigator: Thibault RIANT         
Sub-Investigator: Bruno RIOULT         
Sub-Investigator: Marc SOREL         
Sub-Investigator: Christian GOV         
Sub-Investigator: Franck LE CAER         
Sub-Investigator: Pascale VERGNE-SALLE         
Sub-Investigator: Maryline FEUILLET         
Sub-Investigator: Gilles ALLANO         
Sub-Investigator: Fadel MAAMAR         
Sub-Investigator: Véronique DIXNEUF         
Sub-Investigator: Julien ESNAULT         
Sub-Investigator: Jacques GAILLARD         
Sub-Investigator: Mario BARMAKI         
Sub-Investigator: Olivier COLLARD         
Sub-Investigator: Yves-Marie PLUCHON         
Sub-Investigator: Frédéric PLANTEVIN         
Sub-Investigator: Claire DELORME         
Sub-Investigator: Gilbert ANDRE         
Sub-Investigator: Caroline MAINDET         
Sub-Investigator: Xavier KIEFFER         
Sub-Investigator: Yannick PERIER         
Sub-Investigator: Jean-Marie AMODEO         
Sub-Investigator: Florence TIBERGHIEN         
Sub-Investigator: Mohammed EL AYADI         
Sub-Investigator: Sonia CIESLAK         
Sub-Investigator: Géraldine DEMONTGAZON         
Sub-Investigator: Erik VASSORT         
Sub-Investigator: Jean-Marie LE BORGNE         
Sub-Investigator: Caroline COLOMB         
Sub-Investigator: Rodrigue DELEENS         
Sub-Investigator: Virginie PIANO         
Sub-Investigator: Julien NIZARD         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03319238     History of Changes
Other Study ID Numbers: CHU-349
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Chronic pain
Neuropathic pain
Ketamine
Concomitant treatment
Adverse effect

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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