Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia

NCT06916403 | Active Not Recruiting

• 1 other identifier: WMC003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies of intravenous ketamine, which is a non-competitive N-methyl-D aspartate receptor antagonist, for fibromyalgia pain relief are limited to three studies. Two studies have focused on short-term pain relief of intravenous ketamine by measuring the patients' pain levels immediately before and after the infusion. Currently, existing studies used short-term infusions (30-40 minutes) of sub-anesthetic doses of ketamine for pain relief in fibromyalgia patients, whereas the Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists recommend infusing IV ketamine for at least two hours and a minimal total dose of 80 mg. The rationale of this study is to expand on the existing data of safety and efficacy of intravenous ketamine to relieve fibromyalgia pain. Specifically, this investigation will add data to fill the existing gap regarding the short- and long-term pain relief in the treatment of fibromyalgia with intravenous ketamine infusions. The study will also attempt to determine safety and tolerability. In addition, the characteristics of treatment responders versus non-responders will be assessed in an effort to determine whether specific characteristics can be used to predict treatment response in this group of patients.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Intravenous Ketamine Infusions; Chronic Pain; Neuropathic Pain; Dissociative State; Depression; Pain Relief

Outcome Measures

Primary Outcomes (4)

• Numeric Rating Scale (NRS)

  The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).

  Baseline visit: immediately before IV ketamine infusion

• Numeric Rating Scale (NRS)

  The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).

  Baseline visit: immediately after the IV ketamine infusion

• Numeric Rating Scale (NRS)

  The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).

  Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

• Integral of pain relief

  IPR is a multidimensional measure combining the duration of patients' pain relief (in days) and the percentage of pain relief that they had experienced. IPR seeks to tap into a fuller picture of the patients' pain relief, since it not only measures current pain levels, but patients' experience of pain, both in duration and percentage of relief, over a longer period of time. The scale has no restrictions, beginning at 0 (no treatment effect). Therefore, the higher the IPR value, the more effective the treatment was at reducing pain

  Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

Secondary Outcomes (17)

• The Clinician-Administered Dissociative States Scale (CADSS)

  Baseline visit: immediately before IV ketamine infusion

• The Clinician-Administered Dissociative States Scale (CADSS)

  Baseline visit: 40 minutes after the IV ketamine infusion

• Patient Health Questionnaire (PHQ-9)

  Baseline visit: before IV ketamine infusion

• Patient Health Questionnaire (PHQ-9)

  Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

• Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)

  Baseline visit: before IV ketamine infusion

Study Arms (2)

Prospective Study Group

A total of approximately 30 patients diagnosed with fibromyalgia will be selected for participation in the study, all of whom will be treated with one IV ketamine infusion for pain relief according to their regular schedule of IV ketamine infusions. Each patient will be evaluated at baseline (prior to ketamine infusion), 40 minutes post-infusion, and at follow up visits.

Drug: Intravenous Ketamine Infusions

Retrospective Study group

A total of approximately 20 patients will be selected for participation in the study, all of whom were treated with IV ketamine infusions. Information regarding clinically relevant outcomes will be obtained from chart reviews from patients who meet the eligibility criteria. The patient's response to treatment will be assessed.

Drug: Intravenous Ketamine Infusions

Interventions

Intravenous Ketamine Infusions DRUG

Ketamine will be slowly infused with the routine target dose 1.5-2 mg/kg over 3-4 hours.

Prospective Study Group; Retrospective Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from Wilderman Medical Clinic, a chronic pain clinic located in Thornhill, Ontario. The clinic consists of state-of-the-art out-patient facilities, an interdisciplinary team and nursing support.

You may qualify if:

• To be included in Part 1 of the study, patients must fulfil the following criteria:
• Given written consent to permit Wilderman Medical Clinic investigators to use their medical and demographic information in research studies.
• Male or female \>18 years of age
• Having been diagnosed with fibromyalgia
• Received at least 4 IV ketamine infusion(s)
• Made at least one rating of pain (NRS) immediately before the intervention and one after the intervention
• Had follow-up data recorded on the follow-up visit: percentage and duration of pain relief
• To be included in Part 2 of the study, patients must fulfil the following criteria:
• Male or female \>18 years of age
• Given the written Informed Consent Form to participate in the study
• Having been diagnosed with fibromyalgia
• Having been prescribed IV ketamine infusions treatment
• Passed safety screening for ketamine infusions
• Had at least 3 IV ketamine infusions for dose optimization
• Willingness and ability to comply with the study procedure and the ability to follow verbal and written instructions

You may not qualify if:

• Patients will be excluded from Part 1 of the study if they meet any of the following criteria:
• Age less than 18 years old
• Absence of signed Informed Consent Form
• Patients who received less than 4 IV ketamine infusion(s)
• Insufficient information to conduct analysis (e.g. absence of pain ratings or follow up measurements)
• Patients will be excluded from the Part II of the study if they meet any of the following criteria:
• Age less than 18 years old
• Absence of signed Informed Consent Form
• Received less than 3 IV ketamine infusions
• Have any contradictions to the administration of intravenous ketamine (known allergy to ketamine or fail to pass Ketamine treatment screening)
• Diagnosis of dementia or other cognitive impairments
• Any clinically significant acute or chronic medical condition that in the judgment of Investigator may preclude the use of intravenous ketamine or compromise patient safety, limit patient's ability to complete the study, and/or compromise the objectives of the study.
• Participation in any other clinical study within 3 months prior to screening and during the study period.

Sponsors & Collaborators

• Wilderman Medical Clinic: lead

Study Sites (1)

Wilderman Medical Clinic

Thornhill, Ontario, L4J 1W3, Canada

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Neuralgia; Depression

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Igor Wilderman, MD

  Wilderman Medical Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 8, 2025
• Study Start: November 30, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)