Clinical trial NCT06916403: Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia
Official title: A Two-part Study to Access the Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Intravenous Ketamine Infusions
Chronic Pain
Neuropathic Pain
Dissociative State
Depression
Pain Relief
Lead sponsor: Wilderman Medical Clinic
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Detailed description: This study consists of two parts. The first part is a single-centre, retrospective chart review to analyze and summarize the investigators' experience with intravenous ketamine infusions in the treatment of patients with fibromyalgia who received at least four infusions for pain management. For the second part, patients who already received at least three intravenous ketamine infusions (for optimal dose determination) will be enrolled in an open single-group prospective study to receive one intravenous ketamine treatment. In this prospective study, the investigators will evaluate infusion effectiveness, safety, and tolerability as well as the influence of patients' demographic and medical characteristics, including depression status and ketamine dissociation symptoms, on the treatment outcome.

This two-part study aims to evaluate whether intravenous ketamine is effective in reducing pain in patients diagnosed with fibromyalgia. To achieve this goal, the study will assess the effect of intravenous ketamine infusions on short- and long-term pain relief. The study will also evaluate the safety and tolerability of ketamine infusions in fibromyalgia patients and factors that may have an impact on the treatment outcome.

Eligibility criteria: Inclusion criteria:

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

Exclusion Criteria:

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.

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Baseline visit: immediately before IV ketamine infusion
measure: Numeric Rating Scale (NRS)
timeFrame: Baseline visit: immediately after the IV ketamine infusion
measure: Numeric Rating Scale (NRS)
timeFrame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
measure: Integral of pain relief
timeFrame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Secondary outcomes:
measure: The Clinician-Administered Dissociative States Scale (CADSS)
timeFrame: Baseline visit: immediately before IV ketamine infusion
measure: The Clinician-Administered Dissociative States Scale (CADSS)
timeFrame: Baseline visit: 40 minutes after the IV ketamine infusion
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline visit: before IV ketamine infusion
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
measure: Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
timeFrame: Baseline visit: before IV ketamine infusion
measure: Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
timeFrame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
measure: Fibromyalgia Impact Questionnaire, Revised (FIQR)
timeFrame: Baseline visit: before IV ketamine infusion
measure: Fibromyalgia Impact Questionnaire, Revised (FIQR)
timeFrame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
measure: Patients Global Impression of Change (PGIC)
timeFrame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
measure: Periprocedural adverse effects
timeFrame: Baseline visit: During the infusion
measure: Periprocedural adverse effects
timeFrame: Baseline visit: During the infusion
measure: Periprocedural adverse effects
timeFrame: Baseline visit: During the infusion
measure: Periprocedural adverse effects
timeFrame: Baseline visit: During the infusion
measure: Postprocedural adverse effects
timeFrame: Baseline visit: During 60-90 minutes after the procedure
measure: Postprocedural adverse effects
timeFrame: Baseline visit: During 60-90 minutes after the procedure
measure: Postprocedural adverse effects
timeFrame: Baseline visit: During 60-90 minutes after the procedure
measure: Postprocedural adverse effects
timeFrame: Baseline visit: During 60-90 minutes after the procedure
Other outcomes:
Locations:
city: Thornhill
country: Canada
facility: Wilderman Medical Clinic
state: Ontario
Study officials:
affiliation: Wilderman Medical Clinic
name: Igor Wilderman, MD
role: PRINCIPAL_INVESTIGATOR
References: