OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient cohort<br>Neuropathic pain patient taking ketamine | Other: ketamine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analysis of benefit | 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. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analysis of risk (by collecting adverse event) of ketamine use. | 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,…) | At baseline | 
| Neuropathic Pain in 4 questions (DN4), | 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. | At baseline | 
| Patient Global Impression of Change, the characteristics of pain (PGIC) | 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 | At baseline | 
| Emotional status by Hospital Anxiety and Depression scale (HAD) | 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. | At baseline | 
| Quality of life (Short Form 12 items Short Form survey) | assessed by a quality of life questionnaire (Short Form 12 items Short Form survey (SF12) | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Neuropathic pain, Ketamine, Concomitant treatment, Adverse effect