Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

University at Buffalo (UB)

Status and phase: Enrolling; Phase 3

Conditions: Distal Radius Fracture Reduction; Pain Control; Pediatric Fractures

Treatments: Drug: Ketamine + Lidocaine; Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray); Drug: Ketamine group

Study type: Interventional

Funder types: Other

Identifiers

NCT07120763

STUDY00009073

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Full ketamine sedation

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine group

Hematoma block/minimal ketamine pain control

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine + Lidocaine

hematoma block/intranasal fentanyl

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)