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

NCT ID: NCT06916403

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2025-12-30

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.

Conditions

Fibromyalgia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Intravenous Ketamine Infusions

Intervention Type: DRUG

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

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.

Intravenous Ketamine Infusions

Intervention Type: DRUG

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

Interventions

Intravenous Ketamine Infusions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wilderman Medical Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Igor Wilderman, MD

Role: PRINCIPAL_INVESTIGATOR

Wilderman Medical Clinic

Locations

Wilderman Medical Clinic

Thornhill, Ontario, Canada

Countries

Canada

Other Identifiers

WMC003

Identifier Type: -

Identifier Source: org_study_id