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Ketamine Infusion for Acute Sickle Cell Crisis in the Emergency Department (KISS)

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ClinicalTrials.gov Identifier: NCT02417298
Recruitment Status : Terminated (Feasibility)
First Posted : April 15, 2015
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Billy Sin, The Brooklyn Hospital Center

Brief Summary:
Pain associated with sickle cell disease is a common emergency department visit. It is also frequently associated with a high emergency department recidivism rate for pain control and admissions to the hospital. Opiates are considered the first line therapy for acute flares and to manage chronic pain. This often times leads to a stigma of being "opiate seekers" or "frequent fliers". With this study, we wish to explore whether adding ketamine to standard acute opiate therapy (morphine or dilaudid) will decrease subsequent repeat doses of opiates while improving the patient's perception of pain. In addition, we will be exploring whether ketamine as an adjuvant therapy can help reduce hospital admissions for the management of acute sickle cell crisis pain.

Condition or disease Intervention/treatment Phase
Pain Sickle Cell Disorder Drug: Normal saline Drug: Ketamine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine Infusion for Acute Sickle Cell crisiS in the Emergency Department
Study Start Date : November 2015
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketamine
Ketamine 0.3 mg/kg intravenous push followed by ketamine infusion at 0.1 mg/kg/hr for 3 hours
Drug: Ketamine
0.3mg/kg IVP ketamine followed by 0.1mg/kg/hr of ketamine infusion for 3 hours

Placebo Comparator: Saline
Normal saline intravenous push (with volume to be administered equivalent to that of ketamine 0.3mg/kg, if the patient was to receive ketamine) followed by a normal saline infusion at the same rate as ketamine arm
Drug: Normal saline
Normal saline intravenous push (with volume to be administered equivalent to that of ketamine 0.3mg/kg, if the patient was to receive ketamine) followed by a normal saline infusion at the same rate as ketamine arm




Primary Outcome Measures :
  1. Change in patient's perception of pain [ Time Frame: At baseline, 30, 60, 90, 120, 150 and 180 min after administration of intervention ]
    Pain will be assessed via the Numeric Rated Scale (NRS)

  2. Total number of patients requiring hospital admission [ Time Frame: 180 min after administration of intervention ]
    At the end of the study (180 minutes after initial administration of intervention) the number of patients requiring hospital admission will be quantified


Secondary Outcome Measures :
  1. Change in patient perception of pain after discharge [ Time Frame: 24 and 72 hours post ED discharge ]
    Pain will be assessed via the Numeric Rated Scale (NRS)

  2. Total opiate consumed [ Time Frame: 0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention ]
    If opiates were ordered as part of standard therapy for patient, the total amount of opiates consumed would be quantified

  3. Post test of disability and functional outcomes using the Sickle Cell Pain Burden Interview (SCPBI) [ Time Frame: 180 minutes after initial study intervention ]
  4. Incidence of hypertension [ Time Frame: 0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention ]
  5. Incidence of dissociative effects (characterized by hallucination, disorientation, confusion, agitation, delirium, dreams) [ Time Frame: 0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention ]
  6. Incidence of nausea [ Time Frame: 0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention ]
  7. Incidence of vomiting [ Time Frame: 0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention ]
  8. Incidence of dizziness [ Time Frame: 0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention ]
  9. Incidence of headache [ Time Frame: 0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention ]
  10. Time to patient discharge from the initiation of intervention [ Time Frame: At the end of study period (180 minutes after initiation of study intervention) ]
  11. Patient satisfaction of pain control [ Time Frame: At the end of study period (180 minutes after initiation of study intervention) ]
    To be assessed via a Likert Scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients 18 years old and older presenting with acute sickle cell crisis pain either described as diffuse throughout the body or localized to joint/extremity/back
  • Describes pain to be greater than or equal to 2 on the NRS
  • Consents to IV access
  • Provides informed consent

Exclusion Criteria:

  • Receiving IM therapy only
  • Standard therapy plan is not morphine or dilaudid
  • Previous enrollment in study
  • Documented fever or subjectively reported fever
  • Complaint of chest pain or shortness of breath or abdominal pain or headache
  • Suspicion for acute chest crisis
  • Patients with history or acute diagnosis of subarachnoid hemorrhage/increased intracranial pressure
  • Severe hypertension(≥180/100)
  • History of CAD or hypertension
  • Presence of/suspected for traumatic head injury with or without loss of consciousness
  • Presence of/suspected for myocardial ischemia
  • Presence of/suspected for alcohol intoxication
  • Hemodynamic instability
  • History of psychiatric disorders,
  • Known or suspected pregnancy or breastfeeding
  • Allergy to ketamine
  • Administration of opioids in previous 4 hours
  • Patients with language barriers
  • Ilicit drug use within the past 7 days

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): NCT02417298


Locations
United States, New York
The Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
Sponsors and Collaborators
Billy Sin
Investigators
Principal Investigator: Michael Hochberg, MD The Brooklyn Hospital Center

Publications:

Responsible Party: Billy Sin, Primary investigator, The Brooklyn Hospital Center
ClinicalTrials.gov Identifier: NCT02417298     History of Changes
Other Study ID Numbers: 668842
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Billy Sin, The Brooklyn Hospital Center:
ketamine
pain
sickle cell disorder

Additional relevant MeSH terms:
Emergencies
Anemia, Sickle Cell
Disease Attributes
Pathologic Processes
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