Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine

Phase 3 Recruiting 300 enrolled Assistance Publique - Hôpitaux de Paris URC-CIC Paris Descartes Necker Cochin · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if IN fentanyl (1.5 µg/kg) or IN ketamine (1 mg/kg) is more effective at 30 minutes than oral morphine (0.5 mg/kg) in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.

Timeline

Start: 2025-02-26
Primary completion: 2028-02
Completion: 2028-02

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	1.5 ug/kg	Intranasal
Subject	Ketamine	Small molecule	1 mg/kg	Intranasal
Comparator	Morphine	Other / unclassified	0.5 mg/kg	Oral

Indications

No indication recorded.