NCT06464146 Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
| NCT ID | NCT06464146 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Limb Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2025-02-26 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Hélène CHAPPUY, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06464146 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Limb Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06464146 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT06464146 currently recruiting?
Yes, NCT06464146 is actively recruiting participants. Contact the research team at helene.chappuy@aphp.fr for enrollment information.
Where is the NCT06464146 trial being conducted?
This trial is being conducted at Boulogne-Billancourt, France, Lille, France, Marseille, France, Nantes, France and 1 additional location.
Who is sponsoring the NCT06464146 clinical trial?
NCT06464146 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Hélène CHAPPUY, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 300 participants.