RecruitingPhase 3NCT07120763

Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures


Sponsor

State University of New York at Buffalo

Enrollment

50 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria3

  • Children requiring reduction for distal radius fracture
  • Children presenting to the emergency department
  • Children who are ages 3 to 17 years.

Exclusion Criteria4

  • Pediatric patients \<3 years old
  • Adult patients (i.e. ages 18 or up)
  • Pediatric patients with injury patterns that are not amenable to hematoma block.
  • Children who are not a candidate for sedation related to BMI \> 95%tile for age, ASA class \> 2, Mallampati score \> 2, and pregnant patients

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Interventions

DRUGKetamine + 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

DRUGKetamine 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

DRUGFentanyl (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

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NCT07120763


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