Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures
Recruiting
Phase 3
Interventional Study
Distal Radius Fracture Reduction
Pain Control
Pediatric Fractures
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 3 – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- State University of New York at Buffalo · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 patt…
Contacts