Ketamine Enhances Analgesia and Mood in Chronic Pain Patients

Sponsor
Salem Anaesthesia Pain Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05985811
Collaborator
(none)
500
1
70.9
7.1

Study Details

Study Description

Brief Summary

Most chronic pain patients have mood disorders. The mood disorders may improve with better analgesia produced by Ketamine injections. A prospective study of patients undergoing interventional pain therapy using Ketamine injections. Pre-injection and post-injection patient data is collected. Pain is measured using numeric pain rating scale, and change in pain score by 2-points is considered significant. Sleep is measured using Likert sleep scale, and change in sleep score by 2-points is considered significant. Anxiety is measured using general anxiety disorder (GAD-7) scale, and change in anxiety score by 4-points is considered significant. Depression is measured using patient health questionnaire (PHQ-9), and change in depression score by 5-points is considered significant.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Chronic pain is usually associated with psychological and mood disorders. Many chronic pain patients have various forms of mood abnormalities; and these mood issues may improve with better analgesia produced by Ketamine injections.

    This is a prospective observational study of consenting adult patients who are undergoing interventional pain management. The patients undergo routine interventional pain therapy using Ketamine injections. Pre-injection and post-injection patient data is collected using validated tools. Data collection includes patients' age, psychiatric diagnosis, pain score, sleep score, anxiety score and depression score.

    Pain score is measured using the numeric pain rating scale, and a change in the pain score by 2-points is considered significant. Sleep score is measured using the Likert sleep scale, and a change in the sleep score by 2-points is considered significant. Anxiety is measured using the general anxiety disorder (GAD-7) scale, and a change in the anxiety score by 4-points is considered significant. Depression is measured using the patient health questionnaire (PHQ-9) scale, and a change in the depression score by 5-points is considered significant.

    Data is analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ketamine Analgesia Enhances Functional Quality and Mood in Chronic Pain Patients
    Actual Study Start Date :
    Feb 2, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Pain score, objective measurement using the validated Numeric Pain Rating scale [12 weeks]

      Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

    Secondary Outcome Measures

    1. Sleep quality score, objective measurement using the validated Likert sleep scale [12 weeks]

      Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • adult chronic pain patients

    • associated mood disorder

    • good treatment compliance

    • associated chronic insomnia

    • regular ketamine pain therapy injection

    • consent for clinical record quality assurance review

    Exclusion Criteria:
    • severe cognitive disorder

    • inability to provide consent

    • major neuropsychiatric disorder

    • cannabis use

    • stimulant use

    • substance abuse

    • poor treatment compliance

    • lack of ketamine pain therapy injection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Salem Anaesthesia Pain Clinic Surrey British Columbia Canada V3S 7J1

    Sponsors and Collaborators

    • Salem Anaesthesia Pain Clinic

    Investigators

    • Principal Investigator: Olumuyiwa Bamgbade, MD,FRCPC, Salem Anaesthesia Pain Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Salem Anaesthesia Pain Clinic
    ClinicalTrials.gov Identifier:
    NCT05985811
    Other Study ID Numbers:
    • SalemAnes2018 Ketamine Mood
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Salem Anaesthesia Pain Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 14, 2023