Intranasal Ketamine For Pain Control In Patients With Sickle Cell Disease And Vaso-occlusive Episode (VOE) In The PED
Primary Purpose
Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intranasal ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease
Eligibility 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.
Sites / Locations
- Jacobi Medical Center
- JACOBIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard Analgesia
Intranasal Ketamine + Standard Analgesia
Arm Description
Patients receiving "no intervention" will receive no intranasal ketamine while awaiting intravenous line placement for parenteral pain control.
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).
Outcomes
Primary Outcome Measures
Change in Pain Score Using Wong Baker/FACES (age<11yr)
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.
Change in Pain Score Using Numeric Rating Scale (age>11yr)
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.
Change in Pain Score Using Wong Baker/FACES (age<11yr)
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.
Change in Pain Score Using a Numeric Rating Scale (age>11yr)
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.
Change in Pain Score Using Wong Baker/FACES (age<11yr)
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.
Change in Pain Score Using a Numeric Rating Scale (age>11yr)
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
Additional Opiate Medication
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)
Patient Satisfaction
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)
Rate of Admission
Percentage of patients within each group who are admitted (vs discharged)
Rate of Return Visit
Percentage of patients within each group who have a return visit documented in the electronic medical record within 1 week of the ER visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04150757
Brief Title
Intranasal Ketamine For Pain Control In Patients With Sickle Cell Disease And Vaso-occlusive Episode (VOE) In The PED
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abigail Nixon
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis, Ketamine, Intranasal Ketamine, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
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.
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Analgesia
Arm Type
No Intervention
Arm Description
Patients receiving "no intervention" will receive no intranasal ketamine while awaiting intravenous line placement for parenteral pain control.
Arm Title
Intranasal Ketamine + Standard Analgesia
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Intranasal ketamine
Intervention Description
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 Measure Information:
Title
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Description
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.
Time Frame
30 minutes
Title
Change in Pain Score Using Numeric Rating Scale (age>11yr)
Description
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.
Time Frame
30 minutes
Title
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Description
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.
Time Frame
15 minutes
Title
Change in Pain Score Using a Numeric Rating Scale (age>11yr)
Description
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.
Time Frame
15 minutes
Title
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Description
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.
Time Frame
15 minutes
Title
Change in Pain Score Using a Numeric Rating Scale (age>11yr)
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Additional Opiate Medication
Description
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)
Time Frame
Duration of ED visit, an average of 5 hrs
Title
Patient Satisfaction
Description
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)
Time Frame
At patient disposition, an average of 5 hrs
Title
Rate of Admission
Description
Percentage of patients within each group who are admitted (vs discharged)
Time Frame
Duration of ED visit, an average of 5 hrs
Title
Rate of Return Visit
Description
Percentage of patients within each group who have a return visit documented in the electronic medical record within 1 week of the ER visit.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Nixon, MD
Phone
718-918-5875
Email
abigail.nixon@nychhc.org
First Name & Middle Initial & Last Name & Degree
Jessica Miller Mantell, DO
Phone
718-918-5875
Email
millerj18@nychhc.org
Facility Name
JACOBI
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Nixon, MD
Phone
718-918-5826
Email
abigail.nixon@nychhc.org
12. IPD Sharing Statement
Plan to Share IPD
No
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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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