Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial

Fentanyl and esketamine are both standard of care for treatment of acute severe traumatic pain in the prehospital setting in the Netherlands. However, it is not known whether they are equally effective and safe. It is also not known whether intranasal (IN) administration of fentanyl or esketamine is equally effective and safe as intravenous (IV) administration. The FORE-PAIN trial is a double-blind multi-arm randomized non-inferiority trial comparing Fentanyl IN, esketamine IV and esketamine IN (intervention arms) to fentanyl IV (comparator arm) for prehospital management of traumatic pain. The investigators hypothesize that all intervention arms provide analgesia that is non-inferior to the comparator arm, and that all study arms are equally safe.

NCT Number	NCT06051227
Lead Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Collaborators: Stichting ZiektekostenVerzekering Krijgsmacht, Ambulance Amsterdam
Conditions	Acute Pain Due to Trauma, Analgesia, Fentanyl, Esketamine, Emergency Medical Services
Enrollment	608 participants
Start Date	2024-01-11
Primary Completion	2026-03 (estimated)
Study Completion	2026-03 (estimated)
Updated on ClinicalTrials.gov	2025-01-30