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

Sickle Cell Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04150757
• Other study ID #: 2019-10379
• Status: Recruiting
• Phase: Phase 3
• Start date: August 21, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2021
• Source: New York City Health and Hospitals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Anemia, Sickle Cell
• Intranasal Ketamine
• Ketamine
• Sickle Cell Disease
• Vaso-occlusive Crisis
• Vaso-Occlusive Pain Episode in Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
United States	JACOBI	Bronx	New York
United States	Jacobi Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abigail Nixon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes
Primary	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.	30 minutes
Primary	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.	15 minutes
Primary	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.	15 minutes
Primary	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.	15 minutes
Primary	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.	15 minutes
Secondary	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)	Duration of ED visit, an average of 5 hrs
Secondary	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)	At patient disposition, an average of 5 hrs
Secondary	Rate of Admission	Percentage of patients within each group who are admitted (vs discharged)	Duration of ED visit, an average of 5 hrs
Secondary	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.	1 week