Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Limb Injury
In brief
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.
Key facts
- Study ID
- NCT06464146
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 300
- Starts
- 2025-02-26
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ambroise Paré Hospital — Boulogne-Billancourt, France (enrolling)
- Roger Salengro Hospital — Lille, France (enrolling)
- Timone Hospital — Marseille, France (enrolling)
- Mère-Enfant Hospital — Nantes, France (enrolling)
- Hopital Necker Enfants malades — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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