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
Assistance Publique - Hôpitaux de Paris
300 participants
Feb 26, 2025
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
Inclusion Criteria7
- 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 Criteria16
- 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
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Interventions
oral morphine (0.5 mg / kg)
IN fentanyl (1.5 µg/kg)
IN ketamine (1 mg/kg)
Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06464146