NCT07120763

Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy of a hematoma block and minimal ketamine pain control or hematoma block and intranasal fentanyl in pediatric patients presenting with distal radius fractures requiring reduction, compared to control of standard full conscious sedation using ketamine.

Conditions

• Distal Radius Fracture Reduction
• Pain Control
• Pediatric Fractures

Interventions

Type	Name	Description
DRUG	Ketamine + Lidocaine	Including comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction
DRUG	Ketamine group	Including comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction
DRUG	Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)	Including comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction

Timeline

• Start date: 2025-08-22
• Primary completion: 2026-08-22
• Completion: 2027-08-22
• First posted: 2025-08-13
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study