AntaMIn - Pain reduction for limb injuries in pediatric emergency departments: A Randomised Clinical Trial comparing intranasal Fentanyl or intranasal Ketamine to oral morphine

Phase 1

Conditions: limb injuries, urgency
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: CTIS2023-506803-25-01

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1)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) 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 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, , 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, Contraindication to morphine, mentioned in SmPC, Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids.