Ketamine Sickle Cell Disease

Brief Summary

Sickle cell disease (SCD) often results in acute vaso-occlusive crisis (VOC), an obstruction of blood vessels resulting in ischemic injury and pain. The pain experienced during these episodes is due to a wide range of pathophysiological processes. Though recent studies have begun to unravel the underlying mechanisms of these processes, literature focused on pain management for sickle cell disease is scarce. Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) remain the predominate treatment for VOC. However, the efficacy of these treatments has come into question. A large sub-set of patients with SCD report continued pain despite treatment with opioids. Tolerance and opioid-induced hyperalgesia (OIH) may be responsible for unresponsiveness to opioid-centric treatment modalities. New classes of drugs are being tested to prevent and treat acute pain associated with SCD, but in the meantime physicians are looking to existing therapies to bridge the gap. The N-methyl-d-aspartate (NMDA) receptor has been implicated in both tolerance and OIH. As a NMDA receptor agonist, ketamine has been shown to modulate opioid tolerance and OIH in animal models and clinical settings. Ketamine utilized as a low dose continuous infusion could benefit patients with SCD related pain that are unresponsive to opioid analgesics. Based on limited studies of adjuvant ketamine use for pain management, low-dose ketamine continuous infusion appears safe. Further clinical investigations are warranted to fully support the use of low-dose ketamine infusion in patients with SCD-related pain.

Intervention / Treatment

Randomized Controlled Prospective Clinical Trial
  • Ketamine (DRUG)
    Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour

Condition or Disease

  • SC Disease
  • Pain, Chronic

Phase

  • Phase 3
  • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Sep 01, 2018 ESTIMATED
    Primary Completion: Sep 01, 2019 ESTIMATED
    Completion Date: Nov 01, 2019 ESTIMATED
    Study First Posted: Apr 18, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 24, 2018

    Sponsors / Collaborators

    Lead sponsor is responsible party
    Responsible Party: N/A

    Participant Groups

    • Continuous infusion of Ketamine 0.3 to 0.5 mg/kg per hour PCA Dilaudid 2.0-2.5 mg

    • Patient-controlled analgesia Dilaudid 2.0-2.5 mg

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Subjects diagnosed with sickle cell anemia
    * Adults aged 18 and older
    * Subjects who have given written consent

    Exclusion Criteria:

    * Subjects who are pregnant
    * Subjects younger than 18 years
    * Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other similar medications
    * Subjects who have a contraindication to ketamine

    Primary Outcomes
    • Total opioid Use in milligrams morphine equivalents

    • Pain scores measured on the Visual Analog Scale 0 - 10

    Secondary Outcomes
    • monetary cost of intervention used

    • Length of stay in the hospital

    • Nausea and vomiting scores Visual Analog Scale 0 - 10

    More Details

    NCT Number: NCT03502421
    Acronym: SCD
    Other IDs: Pro00033576
    Study URL: https://clinicaltrials.gov/study/NCT03502421
    Last updated: Sep 29, 2023