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ACTIVE NOT RECRUITING

NCT06916403

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

Sponsor: Wilderman Medical Clinic

View on ClinicalTrials.gov

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.

Official title: A Two-part Study to Access the Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2020-11-30

Completion Date

2025-12-30

Last Updated

2025-04-08

Healthy Volunteers

Conditions

Fibromyalgia

Interventions

DRUG

Intravenous Ketamine Infusions

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

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.

Locations (1)

Wilderman Medical Clinic

Thornhill, Ontario, Canada