Comparing Intranasal and Intravenous Fentanyl and Esketamine for Severe Traumatic Pain Relief in Adults A Phase 3 Randomized Double-Blind Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of fentanyl and esketamine for treating severe traumatic pain before hospital arrival in the Netherlands. This Phase 3 trial compares different ways of giving these medicinesintravenous IV and intranasal INto see if the non-intravenous methods provide pain relief that is not worse than the standard intravenous fentanyl. The study aims to understand whether these approaches are equally safe and effective in managing acute pain caused by trauma. Participants are randomly assigned to one of four groups receiving either fentanyl IV, fentanyl IN, esketamine IV, or esketamine IN. Each group receives an initial dose, with a possible second dose if needed, using either injection or nasal spray depending on the group. The study is double-blind, meaning neither the patients nor the researchers know which treatment is given to avoid bias. Treatments are given once during prehospital care before transportation to the hospital. During the study, participants pain levels are assessed using a numeric rating scale at 10 and 20 minutes after the first medication dose and upon hospital arrival. Researchers also monitor the need for additional doses, patient satisfaction with pain relief, any adverse events, and if treatment unblinding is necessary. The study is expected to continue until March 2026, with all assessments focused on the prehospital period and arrival at the hospital.

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