RecruitingPhase 3NCT06464146

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

300 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IN fentanyl, a drug called IN ketamine, and others for people with limb injury. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMorphine

oral morphine (0.5 mg / kg)

DRUGIN fentanyl

IN fentanyl (1.5 µg/kg)

DRUGIN ketamine

IN ketamine (1 mg/kg)

DRUGNaCl 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

View Full Details on ClinicalTrials.gov

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NCT06464146


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