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The Effectiveness of Continuous Ketamine Infusion (KONTINUE)

Sponsor
Centre Hospitalier Princesse Grace (Other)
Overall Status
Recruiting
CT.gov ID
NCT06131970
Collaborator
(none)
80
Enrollment
1
Location
24.1
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There are different treatment for chronic pain. One possible treatment is intravenous infusions of ketamine.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Ketamine continuous intravenous infusion for 4 days in Hospital with 0.5 mg/kg/day associated with Magnesium Sulfate 1000mg/day.

    Evaluation schedules will be performed at day 15,30 and 60.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effectiveness of Continuous Ketamine Infusion Associated With Magnesium Sulfate for Management of Patient With Chronic Pain : a Prospective Observational Study
    Actual Study Start Date :
    Feb 22, 2022
    Anticipated Primary Completion Date :
    Dec 24, 2023
    Anticipated Study Completion Date :
    Feb 25, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Long-term effectiveness [1 month]

      Improvement of the numerical scale - score 0 to 10 - 10 is the worst

    2. Long-term effectiveness [1 month]

      Clinical Global Impression of Change (CGI-C) - score 1 to 7 - 7 is the worst

    Secondary Outcome Measures

    1. Pain relief [15, 30, 60 days]

      Neuropathic Pain Symptom Inventory (NPSI) - score 0 to 10 - 10 is the worst

    2. Variation of quality of life [15, 30, 60 days]

      Short Form 12 health survey

    3. Variation of quality of life [15, 30, 60 days]

      Hospital Anxiety and Depression scale - score 0 to 21 - 21 is the worst

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pain lasting for more than six months without contraindication to treatment
    Exclusion Criteria:

    • Inability to give consent

    • Severe psychiatric disorder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Princesse Grace Monaco Monaco 98000

    Sponsors and Collaborators

    • Centre Hospitalier Princesse Grace

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Princesse Grace
    ClinicalTrials.gov Identifier:
    NCT06131970
    Other Study ID Numbers:
    • 21-12
    First Posted:
    Nov 15, 2023
    Last Update Posted:
    Nov 15, 2023
    Last Verified:
    Nov 1, 2023
    Keywords provided by Centre Hospitalier Princesse Grace
    Pain
    Neuropathic pain
    Chronic pain
    Fibromyalgia
    Musculoskeletal diseases
    Additional relevant MeSH terms:
    Chronic Pain

    Study Results

    No Results Posted as of Nov 15, 2023