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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

Distal Radius Fracture Reduction

+ Pain Control
+ Pediatric Fractures
From 3 to 17 Years
+7 Eligibility Criteria

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: October 10, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 22, 2025Actual 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 
Principal SponsorState University of New York at Buffalo
Study ContactDr. Ellen Lutnick Lutnick, MD
Last updated: October 10, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 3 to 17 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Distal Radius Fracture Reduction
Pain Control
Pediatric Fractures
Criteria
3 inclusion criteria required to participate
Children requiring reduction for distal radius fracture
Children presenting to the emergency department
Children who are ages 3 to 17 years
4 exclusion criteria prevent from participating
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 full ketamine sedation in setting of distal radius fracture reduction
Group II
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 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

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).

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 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 HospitalBuffalo, United StatesSee the location
Recruiting
One Study Center