Ketamine Enhances Analgesia and Mood in Chronic Pain Patients

NCT ID: NCT05985811

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-02

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mood Disorder; Opioid Mood Insomnia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Salem Anaesthesia Pain Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olumuyiwa Bamgbade, MD,FRCPC

Role: PRINCIPAL_INVESTIGATOR

Salem Anaesthesia Pain Clinic

Locations

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Salem Anaesthesia Pain Clinic

Surrey, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Olumuyiwa Bamgbade, MD,FRCPC

Role: CONTACT

17786286600

Olu Bamgbade, MD,FRCPC

Role: CONTACT

17786286600

Facility Contacts

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Olumuyiwa Bamgbade, MD, FRCPC

Role: primary

+17786286600

Other Identifiers

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SalemAnes2018 Ketamine Mood

Identifier Type: -

Identifier Source: org_study_id

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