Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT07120763
Phase
PHASE3
Status
Recruiting
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Conditions

  • Distal Radius Fracture Reduction
  • Pain Control
  • Pediatric Fractures

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine + Lidocaine — DRUG
    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
  • Ketamine group — DRUG
    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
  • Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) — DRUG
    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

Study Details

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 Dates

Start date
Aug 22, 2025
Status verified
Oct 2025
Primary completion
Aug 22, 2026
Completion
Aug 22, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Full ketamine sedation
    Including group of patients treated with full ketamine sedation in setting of distal radius fracture reduction
  • Active Comparator: Hematoma block/minimal ketamine pain control
    Including group of patients treated with hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction in pediatric patients requiring reduction
  • Active Comparator: hematoma block/intranasal fentanyl
    Including control group of patients treated with intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction

Primary Outcome Measure

Pain control efficacy [ Time Frame: 1 hour after fracture reduction is complete on the day of the procedure/study visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oshei Children's HospitalBuffaloNew York14203
Dr. Tara Petroski Emergency Medicine Physician, MD
[email protected]
716-323-2100

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By research site
Oshei Children's Hospital· Buffalo, NY

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