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

• Sponsor: Abigail Nixon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04150757
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 21.3
• Patients Per Site: 20
• Patients Per Site Per Month: 0.9

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Anticipated 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.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
• Actual Study Start Date: Aug 21, 2020
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Pain Score Using Wong Baker/FACES (age<11yr) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jacobi Medical Center	Bronx	New York	United States	10461
2	JACOBI	Bronx	New York	United States	10461

Sponsors and Collaborators

• Abigail Nixon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Nov 5, 2019
• Last Update Posted: Sep 1, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Anemia, Sickle Cell; Ketamine

Study Results

No Results Posted as of Sep 1, 2021