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RECRUITING
NCT07120763
PHASE3

Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

Sponsor: State University of New York at Buffalo

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

3 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-22

Completion Date

2027-08-22

Last Updated

2025-10-10

Healthy Volunteers

No

Interventions

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

Locations (1)

Oshei Children's Hospital

Buffalo, New York, United States