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

NCT04150757 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: 2019-10379
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Sickle Cell Disease; Vaso-Occlusive Pain Episode in Sickle Cell Disease; Vaso-occlusive Crisis; Ketamine; Intranasal Ketamine; Analgesia

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Additional Opiate Medication

  Duration of ED visit, an average of 5 hrs

• Patient Satisfaction

  At patient disposition, an average of 5 hrs

• Rate of Admission

  Duration of ED visit, an average of 5 hrs

• Rate of Return Visit

  1 week

Study Arms (2)

Standard Analgesia

NO INTERVENTION

Patients receiving "no intervention" will receive no intranasal ketamine while awaiting intravenous line placement for parenteral pain control.

Intranasal Ketamine + Standard Analgesia

ACTIVE COMPARATOR

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

Interventions

Intranasal ketamine DRUG

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.

Intranasal Ketamine + Standard Analgesia

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abigail Nixon: lead

Study Sites (2)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

JACOBI

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Agnosia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Patients and treating providers will be aware of the medication administration.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator, MD

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: November 5, 2019
• Study Start: December 19, 2019
• Primary Completion: October 1, 2020
• Study Completion: June 1, 2022
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)