About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Morphine
- IN fentanyl
- IN ketamine
- NaCl 0,9 %
Treatment groups
Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator