Comparing pain relief methods for children with limb injuries in emergency departments
Pain Reduction for Limb Injuries in Pediatric Emergency Departments: A Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine
PHASE3 · Assistance Publique - Hôpitaux de Paris · NCT06464146
This study is testing whether using nose sprays of fentanyl or ketamine can help relieve pain faster and better than oral morphine for kids aged 2 to 17 with limb injuries in emergency rooms.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 5 sites (Boulogne-Billancourt and 4 other locations) |
| Trial ID | NCT06464146 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of intranasal fentanyl and intranasal ketamine compared to oral morphine in reducing moderate to severe pain in children aged 2 to 17 years with limb injuries. The research focuses on children presenting to emergency departments within 12 hours of their injury, using a pain assessment scale to measure outcomes at 30 minutes post-administration. The study seeks to determine if the non-invasive intranasal route provides faster and more effective pain relief than traditional oral morphine. This approach could potentially improve pain management strategies in pediatric emergency care.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 17 years with moderate to severe pain from limb injuries presenting to the emergency department.
Not a fit: Patients who have received narcotic pain medication prior to arrival or have contraindications to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and rapid pain relief options for children with limb injuries in emergency settings.
How similar studies have performed: While there are no existing studies comparing intranasal fentanyl or ketamine to oral morphine in this specific context, the use of intranasal analgesics has shown promise in other settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boulogne-Billancourt and 4 other locations
- 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)
Study contacts
- Principal investigator: Hélène CHAPPUY, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Hélène CHAPPUY, MD, PhD
- Email: helene.chappuy@aphp.fr
- Phone: +33 1 44 49 41 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Limb Injury, Fentanyl, Ketamin, Limb injury, Pain, Children