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NCT Number: NCT05985811

Ketamine Enhances Analgesia and Mood in Chronic Pain Patients

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.

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Key information

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

Location status: Recruiting

Location contact

Olumuyiwa Bamgbade, MD, FRCPC

CONTACT

[email protected]

+17786286600

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pain score, objective measurement using the validated Numeric Pain Rating scale

    Time frame: 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 outcomes

  1. Sleep quality score, objective measurement using the validated Likert sleep scale

    Time frame: 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Olu Bamgbade, MD,FRCPC

CONTACT

[email protected]

17786286600

Olumuyiwa Bamgbade, MD,FRCPC

CONTACT

[email protected]

17786286600

Sponsors and collaborators

Lead sponsor

Salem Anaesthesia Pain Clinic

Other

Registry information

Official study title

Ketamine Analgesia Enhances Functional Quality and Mood in Chronic Pain Patients

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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