Informations générales (source: ClinicalTrials.gov)
Pain Reduction for Limb Injuries in Pediatric Emergency Departments: A Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2025
février 2028
15 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:34:20 | Contacter | |||
| AP-HP - Hôpital Ambroise Paré | |||||
| AP-HP - Hôpital Louis Mourier | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ambroise Paré Hospital - 92100 - Boulogne Billancourt - France | Marlène MICHELON JOUNEAUX, MD, PhD | Contact (sur clinicalTrials) | |||
| Mère-Enfant Hospital - 44000 - Nantes - France | Adeline BOUCHERON | Contact (sur clinicalTrials) | |||
| Roger Salengro Hospital - 59000 - Lille - France | Melany LIBER, MD, PhD | Contact (sur clinicalTrials) | |||
| Timone Hospital - 13005 - Marseille - France | Aurélie MORAND, MD, PHD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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