Intranasal Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the PED

Phase 3

Terminated

• Conditions: Ketamine; Analgesia; Vaso-Occlusive Pain Episode in Sickle Cell Disease; Sickle Cell Disease; Vaso-occlusive Crisis; Intranasal Ketamine
• Interventions: Drug: Intranasal ketamine

• Registration Number: NCT04150757
• Lead Sponsor: Abigail Nixon

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.

Study Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-11-03
• Study First Posted: 2019-11-05
• Study Start: 2019-12-19
• Primary Completion: 2020-10-01
• Study Completion: 2022-06-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intranasal Ketamine + Standard Analgesia	Intranasal ketamine	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).

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
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)
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)
Rate of Admission	Duration of ED visit, an average of 5 hrs	Percentage of patients within each group who are admitted (vs discharged)
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.

Trial Locations

Locations (2)

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States

JACOBI; 🇺🇸 Bronx, New York, United States