The Effectiveness of Continuous Ketamine Infusion (KONTINUE) (KONTINUE)

November 13, 2023 updated by: Centre Hospitalier Princesse Grace

Effectiveness of Continuous Ketamine Infusion Associated With Magnesium Sulfate for Management of Patient With Chronic Pain : a Prospective Observational Study

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

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

Study Contact

  • Name: Jean-Marie AMODEO, MD
  • Phone Number: 00 377 97 98 97 02
  • Email: jmamodeo@chpg.mc

Study Locations

  • Monaco
      • Monaco, Monaco, 98000
        • Recruiting
        • Centre Hospitalier Princesse Grace
        • Principal Investigator:
          • Jean-Marie AMODEO, MD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with chronic pain treated with ketamine infusion

Description

Inclusion Criteria:

- Pain lasting for more than six months without contraindication to treatment

Exclusion Criteria:

  • Inability to give consent
  • Severe psychiatric disorder

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term effectiveness
Time Frame: 1 month
Improvement of the numerical scale - score 0 to 10 - 10 is the worst
1 month
Long-term effectiveness
Time Frame: 1 month
Clinical Global Impression of Change (CGI-C) - score 1 to 7 - 7 is the worst
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 15, 30, 60 days
Neuropathic Pain Symptom Inventory (NPSI) - score 0 to 10 - 10 is the worst
15, 30, 60 days
Variation of quality of life
Time Frame: 15, 30, 60 days
Short Form 12 health survey
15, 30, 60 days
Variation of quality of life
Time Frame: 15, 30, 60 days
Hospital Anxiety and Depression scale - score 0 to 21 - 21 is the worst
15, 30, 60 days

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Princesse Grace

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)

February 22, 2022

Primary Completion (Estimated)

December 24, 2023

Study Completion (Estimated)

February 25, 2024

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-12

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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