Actively Recruiting
Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-27
300
Participants Needed
5
Research Sites
152 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged 2 years to 17 years and 11 months
- Weight between 10 kg and 100 kg
- Presenting to emergency department with traumatic pain and suspected fracture based on acute deformity
- Experiencing pain and/or limited movement in the injured limb
- Injury occurred within the last 12 hours
- Pain score of at least 60/100 if age 7 years or older, or at least 7/15 if younger than 7 years
- Covered by health insurance
- At least one signed parental informed consent
You will not qualify if you...
- Received narcotic pain medication before arrival
- Contraindication to morphine
- Allergic or sensitive to ketamine, fentanyl, or related substances
- Contraindication to fentanyl or ketamine
- Glasgow Coma Scale score less than 15
- Significant injuries to femur, head, chest, abdomen, or spine
- Open fracture
- Nasal trauma or complete nasal blockage
- Active nosebleed
- Nasal or sinus surgery within past 6 months
- History of high blood pressure, heart disease, congestive heart failure, glaucoma, increased brain pressure, major psychiatric disorder, or liver failure
- Active or past psychiatric disorder
- Known or suspected pregnancy
- Breastfeeding
- Non-French speaking parent or child
- Participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Ambroise Paré Hospital
Boulogne-Billancourt, France, 92100
Actively Recruiting
2
Roger Salengro Hospital
Lille, France, 59000
Actively Recruiting
3
Timone Hospital
Marseille, France, 13005
Actively Recruiting
4
Mère-Enfant Hospital
Nantes, France, 44000
Actively Recruiting
5
Hopital Necker Enfants malades
Paris, France, 75015
Actively Recruiting
Research Team
H
Hélène CHAPPUY, MD, PhD
CONTACT
N
Nelly BRIAND, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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