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

APHP211044

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.

2024-09-01

2027-09-01

2027-09-01

Not yet recruiting

Early phase I

300

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2024-06-18