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Ketamine Infusion for Sickle Cell Pain Crisis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005209
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date January 23, 2020
Estimated Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
Percentage reduction in grand mean opioid consumption from 0 to 72 hours [ Time Frame: baseline, 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Percentage reduction in grand mean pain score using the 11-point visual analog scale [ Time Frame: baseline, 72 hours ]
    Using standard 11-point visual analog pain scale, ranging from 0 = no pain to 10 = worst pain imaginable.
  • Time from inpatient admission to readiness for discharge [ Time Frame: Upon discharge from the hospital (an average of 1 week) ]
  • 30-day hospital readmission rate [ Time Frame: 30 days from discharge ]
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 Infusion for Sickle Cell Pain Crisis
Official Title  ICMJE Early Low-dose Ketamine Infusion Versus Usual Care for Sickle Cell Pain Crisis: a Randomized, Prospective Study.
Brief Summary The purpose of this study is to prospectively study the efficacy of low dose ketamine infusions in treating patients who are admitted to the hospital with a sickle cell pain crisis. Participants will be prospectively randomized in unblinded fashion in the first 12 to 24 hours of an inpatient admission for sickle cell pain crisis to receive pain management without ketamine infusion (Group A) versus pain management that includes low-dose ketamine infusion starting at 0.2mg/kg/h (Group B). The effect of this intervention on various pain management and healthcare utilization outcome measures will be recorded and analyzed to determine whether or not there is a measurable benefit of using ketamine infusions in this patient population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia; Sickle-Cell, With Crisis
  • Acute Pain
Intervention  ICMJE
  • Drug: Ketamine
    The experimental group will receive a ketamine intravenous infusion, initiated at 0.2 mg/kg/hr within the first 12 to 24 hours on an inpatient admission for sickle cell pain crisis, and titrated per hospital policy by the inpatient pain service.
  • Other: Pain management
    Pain management
Study Arms  ICMJE
  • Active Comparator: Pain management without ketamine infusion
    Pain management without ketamine infusion. No other restrictions on pain management or medications.
    Intervention: Other: Pain management
  • Experimental: Pain management with ketamine infusion
    Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.
    Interventions:
    • Drug: Ketamine
    • Other: Pain management
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a pre-existing/known diagnosis of sickle cell disease, prior to the current presentation
  • Admitted to Duke University Hospital with a clinical diagnosis of sickle cell crisis
  • Are at least 18 years old at time of admission
  • Have been admitted to any hospital for sickle cell pain crisis at least twice in the last year
  • Have documented severe pain at time of admission, requiring intravenous opiates
  • Must be able to speak English

Exclusion Criteria:

  • Are greater than 70 years old at time of admission
  • Carry a diagnosis of cirrhosis, elevated intracranial pressure, elevated intraocular pressure, active coronary artery disease, and psychiatric disorders with history of psychosis
  • Are pregnant or breastfeeding
  • Are concomitantly admitted for another medical or surgical problem in addition to sickle cell pain crisis
  • Have been admitted to any hospital for a sickle cell pain crisis greater than 10 times in the last year
  • Were admitted to any hospital for sickle cell pain crisis within the last 30 days
  • Are able to fully and properly consent for their own medical care, with no restrictions or limitations
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Neil Ray, MD 9196811924 neil.d.ray@duke.edu
Contact: David W Creighton, MD david.creighton@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005209
Other Study ID Numbers  ICMJE Pro00100887
Has Data Monitoring Committee Not Provided
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
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date August 2019

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