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Intranasal Ketamine For Pain Control In Patients With Sickle Cell Disease And Vaso-occlusive Episode (VOE) In The PED

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ClinicalTrials.gov Identifier: NCT04150757
Recruitment Status : Not yet recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Abigail Nixon, New York City Health and Hospitals Corporation

Brief Summary:
This will be a descriptive cohort study of intranasal ketamine as the initial analgesic for children with sickle cell disease who present to the pediatric emergency department with vaso-occlusive crisis and are awaiting intravenous line placement.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Vaso-Occlusive Pain Episode in Sickle Cell Disease Vaso-occlusive Crisis Ketamine Intranasal Ketamine Analgesia Drug: Intranasal ketamine Phase 3

Detailed Description:
This will be a prospective observational cohort involving patients 3 to 25 years of age who present to the Pediatric Emergency Department (PED) at Jacobi Medical Center with vaso-occlusive episode (VOE) in moderate-severe pain (FACES or numeric rating scale ≥5) as determined at triage. Currently, the standard of treatment for VOE at our institution is intravenous (IV) line placement and IV opioid analgesia. The patient will receive intranasal (IN) Ketamine as the first parental analgesic, so as to provide more immediate pain relief while they wait for IV placement and IV analgesia, for opioid pain control, which is currently the standard of care at our institution. The primary objective of this study is to describe the analgesic effect of IN ketamine in treating moderate-to-severe pain due to VOE in the pediatric ED as measured by a pain scale rating at various time intervals following administration. Secondary objectives are to describe the effect of IN ketamine on the need for additional doses of opioid medications, patient satisfaction and disposition.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg). This is an observational study.
Masking: None (Open Label)
Masking Description: Patients and treating providers will be aware of the medication administration.
Primary Purpose: Treatment
Official Title: The Use Of Intranasal (IN) Ketamine For Pain Control In Patients With Sickle Cell Disease And Vaso-occlusive Episode (VOE) In The Pediatric Emergency Department
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 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
No Intervention: Standard Analgesia
Patients receiving "no intervention" will receive no intranasal ketamine while awaiting intravenous line placement for parenteral pain control.
Active Comparator: Intranasal Ketamine + Standard Analgesia
Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg).
Drug: Intranasal ketamine
Patients with vaso-occlusive episode and sickle cell disease in moderate to severe pain determined at triage will receive intranasal ketamine while awaiting IV placement.




Primary Outcome Measures :
  1. Change in Pain Score Using Wong Baker/FACES (age<11yr) [ Time Frame: 30 minutes ]
    Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.

  2. Change in Pain Score Using Numeric Rating Scale (age>11yr) [ Time Frame: 30 minutes ]
    Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. For patients 11 yrs and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.

  3. Change in Pain Score Using Wong Baker/FACES (age<11yr) [ Time Frame: 15 minutes ]
    Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.

  4. Change in Pain Score Using a Numeric Rating Scale (age>11yr) [ Time Frame: 15 minutes ]
    Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. For patients older than 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.

  5. Change in Pain Score Using Wong Baker/FACES (age<11yr) [ Time Frame: 15 minutes ]
    Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.

  6. Change in Pain Score Using a Numeric Rating Scale (age>11yr) [ Time Frame: 15 minutes ]
    Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. For patients 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.


Secondary Outcome Measures :
  1. Additional Opiate Medication [ Time Frame: Duration of ED visit, an average of 5 hrs ]
    Number of opiate analgesic doses and a comparison of opiate equivalents/kilogram versus mean dose for prior visits (if the patient has been seen for VOE prior)

  2. Patient Satisfaction [ Time Frame: At patient disposition, an average of 5 hrs ]
    Patient/Parent satisfaction based on questionnaire. Patients will answer based on a 4 point scale (not happy at all/a little happy/happy&satisfied/very happy)

  3. Rate of Admission [ Time Frame: Duration of ED visit, an average of 5 hrs ]
    Percentage of patients within each group who are admitted (vs discharged)

  4. Rate of Return Visit [ Time Frame: 1 week ]
    Percentage of patients within each group who have a return visit documented in the electronic medical record within 1 week of the ER visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of Hemoglobin SS or SC disease
  • Age 3 years old to 25 years old presenting to the PED with vaso-occlusive with moderate-severe pain determined at triage as pain score (FACES or numeric rating scale) ≥ 5
  • Parent or patient willing to provide consent/assent
  • English speaking

Exclusion Criteria:

  • Patient with concern for more severe complications including acute chest, splenic sequestration, sepsis, stroke, non-VOC pain, asthma exacerbation
  • Allergy to ketamine
  • GCS<15
  • Obstructive nasal anatomy as per parent history
  • History of a psychiatric disorder
  • Pregnant patients will be excluded. Female patients > 12 years old are routinely tested for pregnancy in our PED. Patients found to be pregnant will not be enrolled in study.

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): NCT04150757


Locations
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United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Contact: Abigail Nixon, MD    718-918-5875    abigail.nixon@nychhc.org   
Contact: Jessica Miller Mantell, DO    718-918-5875    millerj18@nychhc.org   
Sponsors and Collaborators
Abigail Nixon

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Responsible Party: Abigail Nixon, Principle Investigator, MD, New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier: NCT04150757    
Other Study ID Numbers: 2019-10379
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: No
Additional relevant MeSH terms:
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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