NCT03466242

IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures

IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures. Timmons Z MD, Feudale B MD Children Presenting to the ED With Distal Forearm Extremity Fractures Often Require Re-alignment Under Conscious Sedation. The Objective of This Study is to Evaluate the Sedative, and Analgesic Effects of Intranasal (IN) Dexmedetomidine (DEX) Who Undergo Conscious Sedation for Reduction of Closed Distal Forearm Fractures When Compared to Those Receiving the Standard of Care Intravenous (IV) Ketamine

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Phoenix Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency Department (PED) who undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective is to compare each sedation technique for safety and procedural outcomes.

Detailed description

Distal Forearm fractures are often are displaced requiring conscious sedation for closed reduction in the Emergency Department. Our institution's current standard of care consists of IN Fentanyl for baseline control of pain, and for those fractures requiring reduction; typically IV Ketamine is utilized. Ketamine is typically well tolerated but is not without concerns including hypertension, vomiting, and the rare but serious complication of laryngospasm. Dexmedetomidine (DEX) offers a possible alternative to IV Ketamine. DEX has been used safely in the critical care setting for both pediatrics and adults. It has been well documented as being quite effective in sedation, amnesia and analgesia. Using IN DEX for PED procedural sedation has the potential to obviate the need for IV placement and may offer a better conscious sedation profile than Ketamine with respect to sedation, analgesia, and adverse outcomes. Our overall project would be to assess the efficiency of IN DEX in comparison to IV Ketamine, for proper sedation and analgesic coverage for children undergoing closed reduction of distal forearm fractures.

Conditions

• Conscious Sedation
• Distal Radius Fracture

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
DRUG	Ketamine	Evaluate sedative and analgesic effects of Intravenous Ketamine

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-01-01
• Completion: 2020-03-01
• First posted: 2018-03-15
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study