Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to find out which pain medication works best for children aged 2 to 17 years with limb injuries that are causing moderate to severe pain. Specifically, it compares two forms of medication given through the nose—fentanyl and ketamine—against oral morphine, which is taken by mouth. The goal is to see if the nasal medications can reduce pain more effectively within 30 minutes after being given.

To be eligible for this study, children must be between 2 and 17 years old, weigh between 10 kg and 100 kg, and be experiencing significant pain from a recent limb injury. They need to arrive at the emergency department within 12 hours of their injury and have a specific pain score indicating they are in moderate to severe pain. Parents will need to provide consent for their child to participate. If a child has received pain medication before arriving at the hospital or has certain medical conditions, they may not be eligible. Participants will receive one of the medications and will be monitored for pain relief and any possible side effects. This study aims to improve how we treat pain in young patients with limb injuries in emergency settings.

Gender

ALL

Eligibility criteria

• 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