Fentanyl or esketamine for traumatic pain (FORE-PAIN) trial: study protocol for a double-blind multi-arm randomized non-inferiority trial.
Trials May 26, 2025 Midas N de Grunt, Nurseda Risvanoglu, Johannes A Siegers et al. 1 citation
In a double-blind randomized non-inferiority trial, fentanyl given intravenously (IV) at 1.0 µg/kg is compared with fentanyl intranasally (IN) at 1.25 µg/kg, esketamine IV at 0.2 mg/kg, and esketamine IN at 0.625 mg/kg for acute traumatic pain in adults treated by Emergency Medical Services in the Netherlands. The primary outcome is pain reduction on a 0–10 Numeric Rating Scale at 10 minutes after the first dose, with a non-inferiority margin of 1.0. The trial aims to determine whether the alternative routes and drugs are as effective and safe as intravenous fentanyl, addressing a gap in comparative evidence for prehospital pain management.