Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06916403

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Fibromyalgia Behavior Behavioral Symptoms Chronic Pain Depression Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wilderman Medical Clinic

Thornhill, Ontario, L4J 1W3, Canada

About this study

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 treatment of patients with fibromyalgia who received at least four infusions for pain management. For the second part, patients who already received at least three intravenous ketamine infusions (for optimal dose determination) will be enrolled in an open single-group prospective study to receive one intravenous ketamine treatment. In this prospective study, the investigators will evaluate infusion effectiveness, safety, and tolerability as well as the influence of patients' demographic and medical characteristics, including depression status and ketamine dissociation symptoms, on the treatment outcome.

This two-part study aims to evaluate whether intravenous ketamine is effective in reducing pain in patients diagnosed with fibromyalgia. To achieve this goal, the study will assess the effect of intravenous ketamine infusions on short- and long-term pain relief. The study will also evaluate the safety and tolerability of ketamine infusions in fibromyalgia patients and factors that may have an impact on the treatment outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous Ketamine Infusions

Drug

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

Primary outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: Baseline visit: immediately before IV ketamine infusion

    The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).

  2. Numeric Rating Scale (NRS)

    Time frame: Baseline visit: immediately after the IV ketamine infusion

    The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).

  3. Numeric Rating Scale (NRS)

    Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

    The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).

  4. Integral of pain relief

    Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

    IPR is a multidimensional measure combining the duration of patients' pain relief (in days) and the percentage of pain relief that they had experienced. IPR seeks to tap into a fuller picture of the patients' pain relief, since it not only measures current pain levels, but patients' experience of pain, both in duration and percentage of relief, over a longer period of time. The scale has no restrictions, beginning at 0 (no treatment effect). Therefore, the higher the IPR value, the more effective the treatment was at reducing pain

Secondary outcomes

  1. The Clinician-Administered Dissociative States Scale (CADSS)

    Time frame: Baseline visit: immediately before IV ketamine infusion

    The CADSS is a 27-item scale with 19 subject-rated items and 8 items scored by an observer. The subjective component consists of 19 items which are administered by a clinician who begins each question with the phrase "at this time" and then reads the item to the subject. The subject then endorses one of a range of possible responses: 0 = not at all, 1 = slightly, 2 = moderately, 3 = considerably, 4 = extremely. The subject's response on these 0 to 4 scales is recorded and the clinician moves on to the next item. Three non-empirically derived subscales for the CADSS have been proposed: amnesia (two items), depersonalization (five items), and derealization (12 items).

  2. The Clinician-Administered Dissociative States Scale (CADSS)

    Time frame: Baseline visit: 40 minutes after the IV ketamine infusion

    The CADSS is a 27-item scale with 19 subject-rated items and 8 items scored by an observer. The subjective component consists of 19 items which are administered by a clinician who begins each question with the phrase "at this time" and then reads the item to the subject. The subject then endorses one of a range of possible responses: 0 = not at all, 1 = slightly, 2 = moderately, 3 = considerably, 4 = extremely. The subject's response on these 0 to 4 scales is recorded and the clinician moves on to the next item. Three non-empirically derived subscales for the CADSS have been proposed: amnesia (two items), depersonalization (five items), and derealization (12 items).

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline visit: before IV ketamine infusion

    PHQ-9 is endorsed by the National Institute for Health and Clinical Excellence for use in primary care in measuring baseline depression severity and responsiveness to treatment. The 9 items on the PHQ-9 consist of the 9 criteria on which the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) depressive disorder diagnoses are based. A 4-point scale indicates a degree of severity; items are rated from 0 (not at all) to 3 (nearly every day).

  4. Patient Health Questionnaire (PHQ-9)

    Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

    PHQ-9 is endorsed by the National Institute for Health and Clinical Excellence for use in primary care in measuring baseline depression severity and responsiveness to treatment. The 9 items on the PHQ-9 consist of the 9 criteria on which the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) depressive disorder diagnoses are based. A 4-point scale indicates a degree of severity; items are rated from 0 (not at all) to 3 (nearly every day).

  5. Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)

    Time frame: Baseline visit: before IV ketamine infusion

    The LANSS is a simple and valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). S-LANSS is a modified version of the LANSS pain scale to make it capable of self-completion.

  6. Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)

    Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

    The LANSS is a simple and valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). S-LANSS is a modified version of the LANSS pain scale to make it capable of self-completion.

  7. Fibromyalgia Impact Questionnaire, Revised (FIQR)

    Time frame: Baseline visit: before IV ketamine infusion

    The Fibromyalgia Impact Questionnaire (FIQ) is a commonly used instrument in the evaluation of fibromyalgia patients. The revised FIQ has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. All questions are framed in the context of the past 7 days. The FIQR is divided into three linked sets of domains: (a) 'function' (contains 9 questions), (b) 'overall impact' (contains 2 questions), and (c) 'symptoms' (contains 10 questions). The FIQR is an updated version of the FIQ that has good psychometric properties, can be completed in less than 2 minutes and is easy to score.

  8. Fibromyalgia Impact Questionnaire, Revised (FIQR)

    Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

    The Fibromyalgia Impact Questionnaire (FIQ) is a commonly used instrument in the evaluation of fibromyalgia patients. The revised FIQ has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. All questions are framed in the context of the past 7 days. The FIQR is divided into three linked sets of domains: (a) 'function' (contains 9 questions), (b) 'overall impact' (contains 2 questions), and (c) 'symptoms' (contains 10 questions). The FIQR is an updated version of the FIQ that has good psychometric properties, can be completed in less than 2 minutes and is easy to score.

  9. Patients Global Impression of Change (PGIC)

    Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

    PGIC is a seven-point single-item scale ranging from 'very much worse' to 'very much improved' worse' with 'no change' as the mid-point that evaluates improvement with treatment during a clinical trial.

  10. Periprocedural adverse effects

    Time frame: Baseline visit: During the infusion

    Variations of heart rate (beats per minute)

  11. Periprocedural adverse effects

    Time frame: Baseline visit: During the infusion

    Variations of blood pressure (mmHg)

  12. Periprocedural adverse effects

    Time frame: Baseline visit: During the infusion

    Variations of pulse oxygen saturation (percentage of hemoglobin carrying oxygen)

  13. Periprocedural adverse effects

    Time frame: Baseline visit: During the infusion

    Presence of dizziness, nausea, chest pain, shortness of breast

  14. Postprocedural adverse effects

    Time frame: Baseline visit: During 60-90 minutes after the procedure

    Variations of heart rate (beats per minute)

  15. Postprocedural adverse effects

    Time frame: Baseline visit: During 60-90 minutes after the procedure

    Variations of blood pressure (mmHg)

  16. Postprocedural adverse effects

    Time frame: Baseline visit: During 60-90 minutes after the procedure

    Variations of pulse oxygen saturation (percentage of hemoglobin carrying oxygen)

  17. Postprocedural adverse effects

    Time frame: Baseline visit: During 60-90 minutes after the procedure

    Presence of dizziness, nausea, chest pain, shortness of breast

Sponsors and collaborators

Lead sponsor

Wilderman Medical Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.