Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
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.
Timeline
- Start
- 2024-01-11
- Primary completion
- 2026-03
- Completion
- 2026-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esketamine | Other / unclassified | 0.2 mg/kg | Intravenous |
| Subject | Esketamine | Other / unclassified | 0.625 mg/kg | Intravenous |
| Subject | Fentanyl | Other / unclassified | 1 ug/kg | Intravenous |
| Subject | Fentanyl | Other / unclassified | 1.25 ug/kg | Intravenous |
Indications
No indication recorded.