Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures
NCT ID: NCT07120763
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
50 participants
INTERVENTIONAL
2025-08-22
2027-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Full ketamine sedation
Including group of patients treated with full ketamine sedation in setting of distal radius fracture reduction
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
Hematoma block/minimal ketamine pain control
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
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
hematoma block/intranasal fentanyl
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
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
Interventions
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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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Children presenting to the emergency department
* Children who are ages 3 to 17 years.
Exclusion Criteria
* 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
3 Years
17 Years
ALL
No
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Tara Petroski
Principal Investigator
Locations
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Oshei Children's Hospital
Buffalo, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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STUDY00009073
Identifier Type: -
Identifier Source: org_study_id
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