Clinical trial NCT04150757: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sickle Cell Disease
Vaso-Occlusive Pain Episode in Sickle Cell Disease
Vaso-occlusive Crisis
Ketamine
Intranasal Ketamine
Analgesia
Lead sponsor: New York City Health and Hospitals Corporation
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Pain Score Using Wong Baker/FACES (age<11yr)
timeFrame: 30 minutes
measure: Change in Pain Score Using Numeric Rating Scale (age>11yr)
timeFrame: 30 minutes
measure: Change in Pain Score Using Wong Baker/FACES (age<11yr)
timeFrame: 15 minutes
measure: Change in Pain Score Using a Numeric Rating Scale (age>11yr)
timeFrame: 15 minutes
measure: Change in Pain Score Using Wong Baker/FACES (age<11yr)
timeFrame: 15 minutes
measure: Change in Pain Score Using a Numeric Rating Scale (age>11yr)
timeFrame: 15 minutes
Secondary outcomes:
measure: Additional Opiate Medication
timeFrame: Duration of ED visit, an average of 5 hrs
measure: Patient Satisfaction
timeFrame: At patient disposition, an average of 5 hrs
measure: Rate of Admission
timeFrame: Duration of ED visit, an average of 5 hrs
measure: Rate of Return Visit
timeFrame: 1 week
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: JACOBI
state: New York
Study officials:
References: