Pain control options for children having distal radius fracture reductions
Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures
This will test whether a hematoma block with low-dose ketamine or a hematoma block with intranasal fentanyl controls pain as well as full IV ketamine sedation for children aged 3–17 who need a distal radius fracture reduced.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT07120763 on ClinicalTrials.gov |
What this trial studies
This phase 3 interventional trial compares two less-intensive analgesia strategies against standard full conscious sedation with IV ketamine for pediatric distal radius fracture reductions. Children aged 3–17 presenting to the emergency department who meet eligibility are assigned to receive hematoma block plus minimal IV ketamine, hematoma block plus intranasal fentanyl, or full IV ketamine sedation. Investigators will record pain scores, need for additional analgesia, procedure success, and any adverse events to compare effectiveness and safety. All treatments are delivered in the emergency department at Oishei Children's Hospital.
Who should consider this trial
Good fit: Children aged 3–17 who present to the emergency department with a distal radius fracture requiring closed reduction and who are candidates for hematoma block are ideal for this study.
Not a fit: Children under 3, adults, those with fracture patterns not suitable for hematoma block, or those at high sedation risk (BMI >95th percentile, ASA class >2, Mallampati >2, or pregnant) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could give effective pain relief with less sedation, fewer resources, and potentially lower risk for children during fracture reduction.
How similar studies have performed: Previous smaller studies and routine emergency practice support hematoma blocks and intranasal fentanyl for pediatric fracture pain, but direct head-to-head comparisons with full ketamine sedation are limited.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Buffalo, New York
- Oshei Children's Hospital — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Dr. Ellen Lutnick Lutnick, MD
- Email: ellenlut@buffalo.edu
- Phone: (716) 323-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.