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

NCT06051227 Phase 3 RECRUITING

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.

Details

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	Phase 3
Status	RECRUITING
Enrolment	608
Start date	2024-01-11
Completion	2026-03

Conditions

• Acute Pain Due to Trauma
• Analgesia
• Fentanyl
• Esketamine
• Emergency Medical Services

Interventions

• Fentanyl Citrate
• Esketamine

Primary outcomes

• Change in pain score as measured with Numeric Rating Scale (NRS) — 10 minutes after first drug administration
  NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'

Countries

Netherlands