NaCl 0,9 %: Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.
Study summary
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
Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Degree of pain (M30) — 30 minutes Success: children \<7 years with a pain score assessed by Evendol \< 5 years, 30 minutes after drugs administration, without rescue analgesia. Scale: 0-15 (no pain - painful)
Degree of pain (M30) — 30 minutes Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia. Visual Analog Scale : 0-100 (no pain- painful)
Trial sites (5)
Facility
City
Region
Status
Ambroise Paré Hospital
Boulogne-Billancourt
France
Recruiting
Roger Salengro Hospital
Lille
France
Recruiting
Timone Hospital
Marseille
France
Recruiting
Mère-Enfant Hospital
Nantes
France
Recruiting
Hopital Necker Enfants malades
Paris
France
Recruiting
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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