Fentanyl OR Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)