This observational cohort study (n=500) aims to assess the impact of ketamine injections on analgesia and mood in chronic pain patients with associated mood disorders.
Conducted by Salem Anaesthesia Pain Clinic, the study involves consenting adult patients undergoing routine interventional pain management with ketamine injections. Pre- and post-injection data are collected, including pain scores measured by the numeric pain rating scale, sleep quality assessed using the Likert sleep scale, anxiety levels evaluated through the general anxiety disorder (GAD-7) scale, and depression measured with the patient health questionnaire (PHQ-9). Significant changes in these scores are predefined.
The study plans to enrol an estimated 500 participants, with the primary completion expected by December 2023. The observational design involves analysing data using statistical methods such as Student’s t-test, ANOVA, Pearson Chi-square test, and regression analysis.
The study’s primary outcome measures the pain score over a 12-week period, while secondary outcome measures include sleep quality score over the same duration. Recruitment is ongoing at Salem Anaesthesia Pain Clinic, with eligibility criteria including adult chronic pain patients with associated mood disorders and undergoing regular ketamine pain therapy injections. The study accepts both male and female participants aged between 20 and 99 years.
Trial Details
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.Trial Number NCT05985811