Pain Reduction With Intranasal Medications for Extremity Injuries

Completed · Phase 3

Conditions studied: Pain, Traumatic Limb Injury

In brief

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.

Key facts

Study ID

NCT02778880

Run by

Children's Hospital Medical Center, Cincinnati

People needed

90

Starts

2016-03-31

Expected to finish

2017-03-21

Last updated by the study team

2020-09-01

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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