Evaluation of Sublingual Sufentanil 30 mcg for Treating Moderate to Severe Limb Pain from Single Trauma in Adults at Emergency Departments

What this Trial Is About

Researchers are evaluating the effectiveness of a 30 microgram sublingual sufentanil tablet for managing moderate to severe pain in adults with isolated trauma to an upper or lower limb. This Phase 3 study compares this treatment to the usual pain management protocol used in the emergency department at Clermont-Ferrand. Pain is a common reason for emergency visits, but current opioid treatments have limitations such as long wait times and resource demands, so this study aims to assess if the sublingual tablet offers advantages in acute pain control. Participants are randomly assigned to one of two groups one receiving the standard pain treatment used in the emergency department and the other receiving a single 30 mcg sublingual sufentanil tablet. The study focuses on adults experiencing moderate to severe monotraumatic pain and measures pain levels using a numerical rating scale. The sublingual tablet offers a non-invasive option that may have a faster onset and easier dosing compared to intravenous opioids. During the study, pain scores will be recorded at the start and 60 minutes later to evaluate effectiveness. Additional assessments include monitoring potential side effects, blood pressure, heart rate, oxygen saturation, and breathing rate at multiple time points up to three hours after treatment. Patient satisfaction with pain management will also be measured. The trial starts in April 2025 and will continue until April 2027, ensuring thorough evaluation and safety monitoring.

Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.