Pain Reduction With Intranasal Medications for Extremity Injuries

• Status: Completed
• Trial end date: 2017-03-21
• Target enrollment: 0
• Participant gender: All

Summary

This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine and intranasal fentanyl in children presenting to the Emergency Department with acute extremity injuries.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Fentanyl; Ketamine

Criteria

Inclusion Criteria:

• 8 years to 17 years (up to the 18th birthday)

• Presenting to emergency department with one or more extremity injuries

• Visual analog scale score 35 mm or greater

• Parent or legal guardian present and willing to provide written consent

Exclusion Criteria:

• Received narcotic pain medication prior to arrival

• Evidence of significant head, chest, abdomen, or spine injury

• Glasgow coma score less than 15 or unable to self report pain score

• Nasal trauma or aberrant nasal/airway anatomy

• Active epistaxis

• Allergy to ketamine, fentanyl or meperidine

• Non-English speaking parent and/or child

• History of psychosis

• Postmenarchal female without a urine or serum assay documenting the absence of pregnancy

• Brought in my juvenile detention center or in police custody

• Pregnancy