Intravenous Ketamine Infusions / Fibromyalgia · Observational Study

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

ClinicalTrials.gov · August 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned observational study of intravenous ketamine infusions in fibromyalgia patients, designed to extend limited prior data on short- and long-term pain relief and characterize responder profiles. No results are yet available in this registry entry; the study is currently enrolling by invitation.

What was studied

Observational. Fibromyalgia; age from 18 Years. Intervention: Prospective Study Group; Retrospective Study group. n = 50. 1 site: Canada.

Key findings

Safety

Study characteristics such as full eligibility criteria, blinding, safety monitoring plan, and comparator (if any) are not detailed.

Who this may help

Clinicians should await published results from this trial before considering IV ketamine for fibromyalgia outside experimental settings. The study aims to clarify efficacy and safety of guideline-concordant infusion protocols (≥2 hours, ≥80 mg) compared to prior shorter infusions.

Plain-language summary

This is a clinical trial registry record with no reported results; the study is actively enrolling and designed to generate initial safety and efficacy data on IV ketamine for fibromyalgia.

Study design

As stated by the source record.

MethodsCohort model. Other time perspective. Primary outcome measures: Numeric Rating Scale (NRS) (assessed at Baseline visit: immediately before IV ketamine infusion); Numeric Rating Scale (NRS) (assessed at Baseline visit: immediately after the IV ketamine infusion); Numeric Rating Scale (NRS) (assessed at Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion); Integral of pain relief (assessed at Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion)

DesignObservational

PopulationFibromyalgia; age from 18 Years

Sample size50

InterventionProspective Study Group; Retrospective Study group

Setting1 site: Canada

Reported figures

Quoted from the source exactly as published.

Planned sample size50

Primary outcome measure 1Numeric Rating Scale (NRS) at baseline immediately before IV ketamine infusion

Primary outcome measure 2Numeric Rating Scale (NRS) at baseline immediately after IV ketamine infusion

Primary outcome measure 3Numeric Rating Scale (NRS) at follow-up visits 1, 2, 3, and 4 weeks after IV ketamine infusion

Primary outcome measure 4Integral of pain relief at follow-up visits 1, 2, 3, and 4 weeks after IV ketamine infusion

Clinical bottom line

Caveats

No results reported; this is a registry record only.
Observational design without control arm limits causal inference.
Enrollment by invitation introduces selection bias risk.
Study characteristics such as full eligibility criteria, blinding, safety monitoring plan, and comparator (if any) are not detailed.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational design without control arm or randomization; no blinding described.

Directness

strong

Directly addresses IV ketamine infusions in fibromyalgia patients with pain as primary outcome.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Observational design and enrollment by invitation raise selection bias concerns; methods details sparse.

Sample adequacy

limited

Planned enrollment of 50 participants is modest for characterizing safety and efficacy robustly.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06916403). This is a study registration, not published results. Lead sponsor: Wilderman Medical Clinic. Recruitment status: ENROLLING_BY_INVITATION. Study type: OBSERVATIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Fibromyalgia. Interventions: DRUG: Intravenous Ketamine Infusions. Primary outcome measures: Numeric Rating Scale (NRS) , Baseline visit: immediately before IV ketamine infusion; Numeric Rating Scale (NRS) , Baseline visit: immediately after the IV ketamine infusion; Numeric Rating Scale (NRS) , Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion; Integral of pain relief , Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Wilderman Medical ClinicIntravenous Ketamine InfusionsFibromyalgiaNCT06916403