NCT04150757

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Abigail Nixon · Academic / Other
• Sex: All
• Age: 3 Years – 25 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-19
• Primary completion: 2020-10-01
• Completion: 2022-06-01
• First posted: 2019-11-05
• Last updated: 2024-11-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study