Pain Reduction With Intranasal Medications for Extremity Injuries

Phase 3 Completed 90 enrolled Children's Hospital Medical Center, Cincinnati

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2016-03-31
Primary completion: 2017-02-22
Completion: 2017-03-21

Publications

Frey TM, Florin TA, Caruso M, Zhang N, Zhang Y, Mittiga MR. Effect of Intranasal Ketamine vs Fentanyl on Pain Reduction for Extremity Injuries in Children: The PRIME Randomized Clinical Trial. JAMA Pediatr. 2019 Feb 1;173(2):140-146. doi: 10.1001/jamapediatrics.2018.4582.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fentanyl	Other / unclassified	2 ug/kg	Intranasal
Subject	Ketamine	Small molecule	1.5 mg/kg	Intranasal

Indications

No indication recorded.