Recruiting
Phase 3

Hematoma Block & Ketamine

Sponsor:

State University of New York at Buffalo

Code:

NCT07120763

Conditions

Distal Radius Fracture Reduction

Pain Control

Pediatric Fractures

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

Ketamine + Lidocaine

Ketamine group

Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)

Study Details

Brief 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

Study ID

NCT07120763

Start date

Aug 22, 2025

Status verified date

Oct, 2025

Completion date

Aug 22, 2027

Anticipated

Primary completion date

Aug 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

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

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Dr. Ellen Lutnick Lutnick, MD

(716) 323-2100ellenlut@buffalo.edu

Locations

Oshei Children's Hospital

Recruiting

Buffalo, New York, United States, 14203

Contacts

Dr. Tara Petroski Emergency Medicine Physician, MD

716-323-2100tpetroski@upa.chob.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2025-10-10.