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

October 19, 2017 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand
        • Sub-Investigator:
          • Olivier COLLARD
        • 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:
          • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic pain

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,…)
At baseline
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.
At baseline
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
At baseline
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.
At baseline
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)
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-349

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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