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Ketamine Sickle Cell Disease (SCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03502421
Recruitment Status : Withdrawn (Never IRB approved, no intention to proceed with the study)
First Posted : April 18, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Study Description
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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.


Condition or disease Intervention/treatment Phase
SC Disease Pain, Chronic Drug: Ketamine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Prospective Clinical Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Determine the Efficacy of Ketamine as an Adjunct for Pain Management in Patients With Sickle Cell Crisis
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketamine
Continuous infusion of Ketamine 0.3 to 0.5 mg/kg per hour PCA Dilaudid 2.0-2.5 mg
 Drug: Ketamine
Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour
No Intervention: Opioid Only
Patient-controlled analgesia Dilaudid 2.0-2.5 mg


Outcome Measures
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Primary Outcome Measures :
  1. Total opioid Use in milligrams morphine equivalents [ Time Frame: 1-3 hours ]
    Total opioid Use in milligrams morphine equivalents

  2. Pain scores measured on the Visual Analog Scale 0 - 10 [ Time Frame: 1-3 hours ]
    Pain scores measured on the Visual Analog Scale 0 - 10


Secondary Outcome Measures :
  1. Cost of pharmacotherapy [ Time Frame: 1 day ]
    monetary cost of intervention used

  2. Length of hospital stay [ Time Frame: 1-7 days ]
    Length of stay in the hospital

  3. Nausea and vomiting scores Visual Analog Scale 0 - 10 [ Time Frame: 1-3 hours ]
    Nausea and vomiting scores Visual Analog Scale 0 - 10


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502421


Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Enrico Camporesi, MD University of South Florida
More Information
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Publications:

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03502421    
Other Study ID Numbers: Pro00033576
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of South Florida:
Ketamine
Additional relevant MeSH terms:
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Hemoglobin SC Disease
Chronic Pain
Pain
Neurologic Manifestations
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Ketamine
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action