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NCT07120763 · State University of New York at Buffalo

Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

What this study is about

The aim of this study is to evaluate the effectiveness 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.

View original scientific description

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.

Interventions

DRUG

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

DRUG

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

DRUG

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 measures

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).

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

Where

  • Buffalo, New York

Related conditions & keywords

Distal Radius Fracture ReductionPain ControlPediatric Fractures

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Oct 10, 2025 · Source of record for eligibility and locations

📊
1 of 50 participants interested
2% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Buffalo

New York

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Distal Radius Fracture Reduction Treatment in Buffalo?

Join others in New York exploring innovative treatment options through clinical research

Distal Radius Fracture Reduction Treatment Options in Buffalo, New York

If you're searching for Distal Radius Fracture Reduction treatment in Buffalo, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Buffalo and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Distal Radius Fracture Reduction. All study-related care is provided at no cost to participants.

Local Sites
1 locations in New York
Now Enrolling
Up to 50 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Distal Radius Fracture Reduction?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Distal Radius Fracture Reduction

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Distal Radius Fracture Reduction Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07120763. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.