Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia (NCT06916403) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia
Canada50 participantsStarted 2020-11-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 stud…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numeric Rating Scale (NRS)
Timeframe: Baseline visit: immediately before IV ketamine infusion
2
Numeric Rating Scale (NRS)
Timeframe: Baseline visit: immediately after the IV ketamine infusion
3
Numeric Rating Scale (NRS)
Timeframe: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
4
Integral of pain relief
Timeframe: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion