OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN

Ketamine

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.

Intervention / Treatment

  • Ketamine (OTHER)
    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

  • Chronic Pain

Phase

Study Design

Study type: OBSERVATIONAL
Status: Unknown status
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 1000 (ESTIMATED)
Funded by: Other
Time Perspective: Prospective
Observational Model: Cohort

Masking

Clinical Trial Dates

Start date: Jul 07, 2016 ACTUAL
Primary Completion: Sep 01, 2018 ESTIMATED
Completion Date: Nov 01, 2018 ESTIMATED
Study First Posted: Oct 24, 2017 ACTUAL
Results First Posted: Aug 31, 2020
Last Updated: Oct 19, 2017

Sponsors / Collaborators

Lead Sponsor: University Hospital, Clermont-Ferrand
Lead sponsor is responsible party
Responsible Party: N/A

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.

Participant Groups

  • Neuropathic pain patient taking ketamine

Eligibility Criteria

Sex: All
Minimum Age: 18
Age Groups: Adult / Older Adult
Healthy Volunteers: Yes

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

Primary Outcomes

  • 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 Outcomes

  • 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,...)

  • 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.

  • 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

  • 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.

  • assessed by a quality of life questionnaire (Short Form 12 items Short Form survey (SF12)

More Details

NCT Number: NCT03319238
Acronym: OKAPI
Other IDs: CHU-349
Study URL: https://clinicaltrials.gov/study/NCT03319238
Last updated: Sep 29, 2023