Clinical TrialFibromyalgiaKetamineKetamineActive not recruiting

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

This two-part observational trial (n=50) will evaluate the safety and efficacy of intravenous ketamine infusions (1.5–2 mg/kg over 3–4 hours) in reducing pain among patients diagnosed with fibromyalgia.

Target Enrollment
50 participants
Study Type
observational
Design
Non-randomized

Detailed Description

Rationale: existing evidence for IV ketamine in fibromyalgia is limited and largely short-term; this study aims to expand data on short- and long-term pain relief and safety/tolerability.

Design: two-part single-centre study (Wilderman Medical Clinic). Part 1: retrospective chart review of patients with ≥4 infusions. Part 2: open single-group prospective study enrolling patients with ≥3 prior infusions to receive one IV ketamine infusion and standardised assessments.

Outcomes: primary focus on change in pain (NRS) at acute and follow-up timepoints; secondary analyses include safety/tolerability, dissociative symptoms, depressive status and characteristics of responders vs non-responders.

Study Protocol

Preparation

sessions

Dosing

1 sessions
240 min each

Integration

sessions

Study Arms & Interventions

Prospective Study Group

experimental

Approximately 30 patients will receive a single IV ketamine infusion as part of a prospective single-group study; assessments at baseline, 40 minutes post-infusion and follow-up visits.

Interventions

  • Ketamine1.5 - 2 mg/kg
    via IV• single dose• 1 doses total

    Infused over 3–4 hours; routine target dose 1.5–2 mg/kg.

Retrospective Study Group

experimental

Chart review of ~20 patients who previously received IV ketamine infusions for fibromyalgia (≥4 infusions) to summarise clinically relevant outcomes.

Interventions

  • Ketamine1.5 - 2 mg/kg
    via IV• multiple• 4 doses total

    Retrospective group received ≥4 prior infusions; routine dosing reported as 1.5–2 mg/kg over 3–4 hours.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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.

Study Details

  • Status
    Active not recruiting
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment50 participants
  • Timeline
    Start: 2020-11-30
    End: 2025-12-30
  • Compounds
    KetamineKetamine
  • Topic
    Fibromyalgia

Locations

Wilderman Medical Clinic — Thornhill, Ontario, Canada

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