Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

NCT07120763 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: STUDY00009073
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distal Radius Fracture Reduction; Pain Control; Pediatric Fractures

Outcome Measures

Primary Outcomes (2)

• Pain control efficacy

  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).

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

• Patient satisfaction scores

  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.

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

Study Arms (3)

Full ketamine sedation

ACTIVE COMPARATOR

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

Drug: Ketamine group

Hematoma block/minimal ketamine pain control

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

Drug: Ketamine + Lidocaine

hematoma block/intranasal fentanyl

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

Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)

Interventions

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

Hematoma block/minimal ketamine pain control

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

Full ketamine sedation

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

Also known as: fentanyl + lidocaine

hematoma block/intranasal fentanyl

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Oshei Children's Hospital

Buffalo, New York, 14203, United States

RECRUITING

Related Publications (5)

• McCarty EC, Mencio GA, Walker LA, Green NE. Ketamine sedation for the reduction of children's fractures in the emergency department. J Bone Joint Surg Am. 2000 Jul;82-A(7):912-8. doi: 10.2106/00004623-200007000-00002.

  PMID: 10901305 BACKGROUND

• Disel NR, Yilmaz HL, Sertdemir Y, Yesilagac H, Avci A. Etomidate Versus Ketamine: Effective Use in Emergency Procedural Sedation for Pediatric Orthopedic Injuries. Pediatr Emerg Care. 2016 Dec;32(12):830-834. doi: 10.1097/PEC.0000000000000373.

  PMID: 25834964 BACKGROUND

• Jordan RW, Aquilina A, Westacott DJ, Cooke S. A comparison of ketamine sedation and general anaesthesia for manipulation of paediatric forearm fractures. Acta Orthop Belg. 2016 Dec;82(4):836-842.

  PMID: 29182126 BACKGROUND

• Morrison T, Carender C, Kilbane B, Liu RW. Procedural Sedation With Ketamine Versus Propofol for Closed Reduction of Pediatric Both Bone Forearm Fractures. Orthopedics. 2017 Sep 1;40(5):288-294. doi: 10.3928/01477447-20170824-01. Epub 2017 Sep 7.

  PMID: 28877328 BACKGROUND

• Kwong A, Aldridge ES, Jayawardana R, Brookwick A, Miller J, Buntine PG. Length of stay outcomes in patients receiving ketamine sedation versus Bier's block anaesthesia for procedural closed fracture reduction: A retrospective audit of paediatric emergency department patients. Emerg Med Australas. 2022 Feb;34(1):73-77. doi: 10.1111/1742-6723.13844. Epub 2021 Aug 29.

  PMID: 34459117 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Lidocaine; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Dr. Ellen Lutnick Lutnick, MD

CONTACT

(716) 323-2100; ellenlut@buffalo.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: August 13, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): August 22, 2026
• Study Completion (Estimated): August 22, 2027
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)