NCT06051227

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 608 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Fentanyl Citrate	Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
DRUG	Esketamine	Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal

Timeline

• Start date: 2024-01-11
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-09-22
• Last updated: 2025-01-30

Locations

1 site across 1 country: Netherlands