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Recruiting NCT05985811

Ketamine Enhances Analgesia and Mood in Chronic Pain Patients

Observational Mood Disorder; Opioid Mood Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Mood Disorder; Opioid, Mood Insomnia. Basic parameters: 20 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Ketamine Analgesia Enhances Functional Quality and Mood in Chronic Pain Patients

Overview

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

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.

Primary outcome measures

  • Pain score, objective measurement using the validated Numeric Pain Rating scale [Time frame: 12 weeks]
Secondary outcome measures (1)
  • Sleep quality score, objective measurement using the validated Likert sleep scale [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Salem Anaesthesia Pain Clinic — Surrey

Identifiers

NCT: NCT05985811 · SalemAnes2018 Ketamine Mood

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗