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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Recruitment Status : Withdrawn (Never IRB approved, no intention to proceed with the study)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

Tracking Information
First Submitted Date  ICMJE April 10, 2018
First Posted Date  ICMJE April 18, 2018
Last Update Posted Date September 26, 2018
Estimated Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • Total opioid Use in milligrams morphine equivalents [ Time Frame: 1-3 hours ]
    Total opioid Use in milligrams morphine equivalents
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • Cost of pharmacotherapy [ Time Frame: 1 day ]
    monetary cost of intervention used
  • Length of hospital stay [ Time Frame: 1-7 days ]
    Length of stay in the hospital
  • Nausea and vomiting scores Visual Analog Scale 0 - 10 [ Time Frame: 1-3 hours ]
    Nausea and vomiting scores Visual Analog Scale 0 - 10
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Sickle Cell Disease
Official Title  ICMJE A Randomized Controlled Trial to Determine the Efficacy of Ketamine as an Adjunct for Pain Management in Patients With Sickle Cell Crisis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Controlled Prospective Clinical Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • SC Disease
  • Pain, Chronic
Intervention  ICMJE Drug: Ketamine
Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour
Study Arms  ICMJE
  • Experimental: Ketamine
    Continuous infusion of Ketamine 0.3 to 0.5 mg/kg per hour PCA Dilaudid 2.0-2.5 mg
    Intervention: Drug: Ketamine
  • No Intervention: Opioid Only
    Patient-controlled analgesia Dilaudid 2.0-2.5 mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 24, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2018)
60
Estimated Study Completion Date  ICMJE November 1, 2019
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03502421
Other Study ID Numbers  ICMJE Pro00033576
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of South Florida
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of South Florida
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Enrico Camporesi, MD University of South Florida
PRS Account University of South Florida
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP