Recruiting

Pain Control Methods for Children with Distal Radius Fractures

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What is being tested

Ketamine + Lidocaine

+ Ketamine group

+ Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)

Drug
Who is being recruted

Agnosia+4

+ Nervous System Diseases

+ Neurologic Manifestations

From 3 to 17 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorState University of New York at Buffalo
Study ContactDr. Ellen Lutnick Lutnick, MD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 22, 2025

Actual date on which the first participant was enrolled.

This study focuses on finding effective ways to manage pain in children who have broken a specific bone in their wrist, known as a distal radius fracture. The research is important because it explores pain relief options that might be safer or more comfortable than the usual method of full conscious sedation with ketamine. The study is comparing two different combinations of treatments: one using a hematoma block with minimal ketamine and the other using a hematoma block with intranasal fentanyl. The goal is to see which of these methods controls pain effectively while potentially offering an improved experience for young patients. Participants in the study will receive either one of the two new pain control methods or the standard approach with ketamine. A hematoma block, which involves injecting medication directly into the area around the broken bone, is used in both new methods. In one method, this is combined with a small dose of ketamine, and in the other, with a dose of fentanyl delivered through the nose. The study will evaluate how well these methods manage pain by observing the patients and assessing their comfort levels during the treatment process. By comparing these approaches, the study aims to identify the most effective and patient-friendly option for managing pain in children with wrist fractures.

Official TitlePain Control Alternatives in Pediatric Patients With Distal Radius Fractures 
NCT07120763
Principal SponsorState University of New York at Buffalo
Study ContactDr. Ellen Lutnick Lutnick, MD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AgnosiaNervous System DiseasesNeurologic ManifestationsPerceptual DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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

Group II

Active Comparator
Including group of patients treated with full ketamine sedation in setting of distal radius fracture reduction

Group III

Active Comparator
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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Oshei Children's Hospital

Buffalo, United StatesSee the location
Recruiting
One Study Center