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RECRUITING
NCT06464146
PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Pain Reduction for Limb Injuries in Pediatric Emergency Departments: A Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-02-26

Completion Date

2028-02

Last Updated

2026-03-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Morphine

oral morphine (0.5 mg / kg)

DRUG

IN fentanyl

IN fentanyl (1.5 µg/kg)

DRUG

IN ketamine

IN ketamine (1 mg/kg)

DRUG

NaCl 0,9 %

Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.

Locations (5)

Ambroise Paré Hospital

Boulogne-Billancourt, France

Roger Salengro Hospital

Lille, France

Timone Hospital

Marseille, France

Mère-Enfant Hospital

Nantes, France

Hopital Necker Enfants malades

Paris, France