Pain Control Alternatives for Pediatric Distal Radius Fractures

This study is looking at different ways to manage pain in children aged 3 to 17 who have a broken wrist bone (distal radius fracture) that needs to be reset. Researchers are comparing three pain control methods: full sedation with ketamine, a combination of a hematoma block (an injection of numbing medicine near the fracture) and a small dose of ketamine, or a hematoma block combined with fentanyl nasal spray. The goal is to see which method is most effective at controlling pain and how satisfied patients are with their pain relief. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This interventional study is comparing three different pain control methods in children. It plans to enroll 50 participants aged 3 to 17 years.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Pain control efficacy and patient satisfaction scores will be measured 1 hour after the fracture reduction is complete on the day of the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07120763

Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

Recruiting
PHASE3Ages 3–17InterventionalTreatment
State University of New York at Buffalo
~50 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:Ketamine + LidocaineKetamine groupFentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain control efficacy
Measured over 1 hour after fracture reduction is complete on the day of the procedure/study visit.
+1 more outcome measured
Distal Radius Fracture Reduction
Pain Control
Pediatric Fractures
1 sites across 1 states
New York1

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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
  • Pain control efficacy1 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).

  • Patient satisfaction scores1 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.