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NCT06131970 Clinical Trial

The Effectiveness of Continuous Ketamine Infusion (KONTINUE)

Chronic Pain Clinical Trial

— KONTINUE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06131970
Other study ID # 21-12
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 22, 2022
Est. completion date February 25, 2024

Study information
Verified date November 2023
Source Centre Hospitalier Princesse Grace
Contact Jean-Marie AMODEO, MD
Phone 00 377 97 98 97 02
Email jmamodeo@chpg.mc
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date February 25, 2024
Est. primary completion date December 24, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pain lasting for more than six months without contraindication to treatment Exclusion Criteria: - Inability to give consent - Severe psychiatric disorder

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Monaco Centre Hospitalier Princesse Grace Monaco

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Princesse Grace

Country where clinical trial is conducted

Monaco, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term effectiveness Improvement of the numerical scale - score 0 to 10 - 10 is the worst 1 month
Primary Long-term effectiveness Clinical Global Impression of Change (CGI-C) - score 1 to 7 - 7 is the worst 1 month
Secondary Pain relief Neuropathic Pain Symptom Inventory (NPSI) - score 0 to 10 - 10 is the worst 15, 30, 60 days
Secondary Variation of quality of life Short Form 12 health survey 15, 30, 60 days
Secondary Variation of quality of life Hospital Anxiety and Depression scale - score 0 to 21 - 21 is the worst 15, 30, 60 days
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