Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia
Lead Sponsor:
Wilderman Medical Clinic
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
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 sh...
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 treatm...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06916403
Start Date
November 30 2020
End Date
December 30 2025
Last Update
April 8 2025
Active Locations (1)
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1
Wilderman Medical Clinic
Thornhill, Ontario, Canada, L4J 1W3