Comparing pain relief methods for children with limb injuries in emergency departments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.