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Clinical Trials in France / NCT06464146
Recruiting Phase 3

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

NCT06464146 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-02-26
Last updated
2026-03-27

Condition(s) studied

Limb Injury

Investigational drug(s) / intervention(s)

Morphine →IN fentanyl →IN ketamine →NaCl 0,9 % →

Morphine: oral morphine (0.5 mg / kg)

IN fentanyl: IN fentanyl (1.5 µg/kg)

IN ketamine: IN ketamine (1 mg/kg)

NaCl 0,9 %: Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.

Study 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

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Child aged 2 years to 17 years and 11 months * With 10 kg ≤ Weight ≤ 100 kg * Presenting to ED with a traumatic pain and suspected fracture(s) based on an acute deformity AND experiencing pain and/or functional impotence in the injured limb(s) * Within the first 12 hours after the injury * VAS pain score at ED arrival ≥ 60/100 (if child ≥ 7 years) or Evendol pain score at ED arrival ≥ 7/15 (if child \< 7 years) * Affiliated to health insurance * At least one signed parental informed consent Exclusion Criteria: * Received narcotic pain medication prior to arrival * Contraindication to morphine, mentioned in SmPC * Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids. * Contraindication to fentanyl or ketamine, mentioned in SmPC * GCS \<15 * Evidence of significant femur, head, chest, abdominal, or spine injury * Open fracture * Nasal trauma or complete nasal obstruction * Active epistaxis * Nasal or sinus surgery within 6 months before inclusion * History of high blood pressure, known coronary artery disease, congestive heart failure, acute glaucoma, increased intracranial pressure, major psychiatric disorder, hepatocellular insufficiency * Active or history of psychiatric disorder * Known pregnancy or suspicion of being pregnant * Breastfeeding * Non-French speaking parent and / or child. * Participation to another interventional clinical research

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Ambroise Paré Hospital Boulogne-Billancourt France Recruiting
Roger Salengro Hospital Lille France Recruiting
Timone Hospital Marseille France Recruiting
Mère-Enfant Hospital Nantes France Recruiting
Hopital Necker Enfants malades Paris France Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06464146 on ClinicalTrials.gov ↗ ← All trials in France