Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

Not Applicable

Not yet recruiting

• Conditions: Distal Radius Fracture Reduction; Pediatric Fractures; Pain Control
• Interventions: Drug: Ketamine group; Drug: Ketamine + Lidocaine; Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)

• Registration Number: NCT07120763
• Lead Sponsor: State University of New York at Buffalo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-15
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-08-30
• Primary Completion: 2026-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full ketamine sedation	Ketamine group	Including group of patients treated with full ketamine sedation in setting of distal radius fracture reduction
Hematoma block/minimal ketamine pain control	Ketamine + Lidocaine	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
hematoma block/intranasal fentanyl	Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)	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

Primary Outcome Measures

Name	Time	Method
Pain control efficacy	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	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.

Trial Locations

Locations (1)

Oshei Children's Hospital; 🇺🇸 Buffalo, New York, United States