Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intra… (NCT06464146) | Clinical Trial Compass
RecruitingPhase 3
Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
France300 participantsStarted 2025-02-26
Plain-language 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.
Who can participate
Age range2 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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