RecruitingPhase 3ketamine
Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
Sponsored by Assistance Publique - Hôpitaux de Paris
NCT ID
NCT06464146
Target Enrollment
300 participants
Start Date
2025-02-26
Est. Completion
2028-02
About This Study
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.
Conditions Studied
Interventions
- •Morphine
- •IN fentanyl
- •IN ketamine
- •NaCl 0,9 %
Eligibility
Age:2 Years - 17 Years
Healthy Volunteers:No
View full 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
Study Locations (5)
Ambroise Paré Hospital
Boulogne-Billancourt, France
Roger Salengro Hospital
Lille, France
Timone Hospital
Marseille, France
Mère-Enfant Hospital
Nantes, France
Hopital Necker Enfants malades
Paris, France