OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN

NCT03319238 | Unknown

• 1 other identifier: CHU-349
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic pain; Neuropathic pain; Ketamine; Concomitant treatment; Adverse effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Descriptive analysis of risk (by collecting adverse event) of ketamine use.

  At baseline

• Neuropathic Pain in 4 questions (DN4),

  At baseline

• Patient Global Impression of Change, the characteristics of pain (PGIC)

  At baseline

• Emotional status by Hospital Anxiety and Depression scale (HAD)

  At baseline

• Quality of life (Short Form 12 items Short Form survey)

  At baseline

Study Arms (1)

Patient cohort

Neuropathic pain patient taking ketamine

Other: ketamine

Interventions

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.

Patient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pain

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• Corriger A, Voute M, Lambert C, Pereira B, Pickering G; OKAPI Consortium. Ketamine for refractory chronic pain: a 1-year follow-up study. Pain. 2022 Apr 1;163(4):690-701. doi: 10.1097/j.pain.0000000000002403.

  PMID: 34252909 DERIVED

MeSH Terms

Conditions

Chronic Pain; Neuralgia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: October 24, 2017
• Study Start: July 7, 2016
• Primary Completion: September 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

FR (1)