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NCT Number: NCT07120763

Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

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.

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Key information

Conditions

Distal Radius Fracture Reduction Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Control Pathological Conditions, Signs and Symptoms Pediatric Fractures Perceptual Disorders Signs and Symptoms

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oshei Children's Hospital

Buffalo, New York, 14203, United States

Location status: Recruiting

Location contact

Dr. Tara Petroski Emergency Medicine Physician, MD

CONTACT

[email protected]

716-323-2100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: fentanyl + lidocaine

Primary outcomes

  1. Pain control efficacy

    Time frame: 1 hour after fracture reduction is complete on the day of the procedure/study visit.

    Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining Visual Analog Scale (VAS) pain scores for each group to determine pain control efficacy and to compare between groups. This is a numeric pain scale with associated faces to help children determine their pain level, with 0 being "no pain" (with a smiley/happy face) and 10 being "most pain possible" (with a sad/crying face).

  2. Patient satisfaction scores

    Time frame: 1 hour after fracture reduction is complete on the day of the procedure/study visit.

    Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining patient satisfaction scores via a 5-point Likert scale to compare patient satisfaction between groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Ellen Lutnick Lutnick, MD

CONTACT

[email protected]

(716) 323-2100

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 13, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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