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

NCT ID: NCT04150757

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2022-06-01

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Analgesia

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: ACTIVE_COMPARATOR

Intranasal ketamine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abigail Nixon

OTHER

Sponsor Role: lead

Responsible Party

Abigail Nixon

Principle Investigator, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Jacobi Medical Center

The Bronx, New York, United States

JACOBI

The Bronx, New York, United States

Countries

United States

Other Identifiers

2019-10379

Identifier Type: -

Identifier Source: org_study_id