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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

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.

Condition or disease Intervention/treatment Phase
Anemia; Sickle-Cell, With Crisis Acute Pain Drug: Ketamine Other: Pain management Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Low-dose Ketamine Infusion Versus Usual Care for Sickle Cell Pain Crisis: a Randomized, Prospective Study.
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Pain management without ketamine infusion
Pain management without ketamine infusion. No other restrictions on pain management or medications.
Other: Pain management
Pain management

Experimental: Pain management with ketamine infusion
Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.
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




Primary Outcome Measures :
  1. Percentage reduction in grand mean opioid consumption from 0 to 72 hours [ Time Frame: baseline, 72 hours ]

Secondary Outcome Measures :
  1. 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.

  2. Time from inpatient admission to readiness for discharge [ Time Frame: Upon discharge from the hospital (an average of 1 week) ]
  3. 30-day hospital readmission rate [ Time Frame: 30 days from discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04005209


Contacts
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Contact: Neil Ray, MD 9196811924 neil.d.ray@duke.edu
Contact: David W Creighton, MD david.creighton@duke.edu

Locations
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United States, North Carolina
Duke Hospital
Durham, North Carolina, United States, 27710
Contact: David W Creighton, MD       david.creighton@duke.edu   
Contact: Neil Ray, MD       neil.d.ray@duke.edu   
Sub-Investigator: David W Creighton, MD         
Sub-Investigator: Nirmish Shah, MD         
Principal Investigator: Neil Ray, MD         
Sub-Investigator: Milly Rambhia, MD         
Sub-Investigator: Elizabeth Gauthier, MD         
Sub-Investigator: Christian Horazeck, MD         
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04005209    
Other Study ID Numbers: Pro00100887
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: August 2019
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 Duke University:
Ketamine
Intravenous Infusions
Anemia; Sickle-Cell, with Crisis
Acute Pain
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Acute Pain
Anemia
Hematologic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
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