Efficacy and Safety of Intravenous Sufentanil Administration in Low-Severity Acute Trauma as A Competence of Paramedics: A Follow-Up Observational Study

Background and importance In the Czech Republic, paramedics are required to consult a physician before administering intravenous opioids, which may delay effective prehospital pain management. As paramedic competencies expand in Europe, it is important to evaluate the safety and efficacy of independent opioid administration in real-world emergency medical settings. Objectives To assess the safety and effectiveness of intravenous sufentanil administered independently by trained paramedics compared to administration following remote physician consultation in adult trauma patients. Design Prospective, single-center, observational cohort study. Settings and participants Conducted at the Emergency Medical Services of the Karlovy Vary Region between January 1 and December 31, 2024. The study included 462 adult trauma patients who were hemodynamically stable and conscious. Patients were divided into two groups: the Consultation group (physician consultation required) and the Competency group (paramedics administering independently). Intervention or exposure Intravenous administration of sufentanil, with or without physician phone consultation. Outcome measures and analysis Primary outcomes included reduction in pain (measured using the Numeric Rating Scale, NRS) and incidence of adverse events (e.g., respiratory depression, oxygen desaturation, hypotension, and antiemetic use). Statistical significance was set at p<0.05. Main results Both groups achieved similar pain reduction. The Competency group received a higher mean dose of sufentanil (9.7 ± 3.0 µg vs 8.9 ± 2.8 µg; p=0.006) and more frequently used non-opioid adjuvant analgesics (54% vs 41%). Documentation of pain scores was significantly better in the Competency group (87% vs 43%; p<0.01). Adverse events were rare, non-serious, and comparable between groups. Antiemetics were more frequently administered in the Competency group (11% vs 6%; p=0.037). A minor, clinically insignificant reduction in diastolic blood pressure was observed in the Competency group. Conclusion Independent administration of intravenous sufentanil by trained paramedics was as safe and effective as physician-supervised administration, with better documentation and more frequent multimodal analgesia. These findings support expanding paramedic competencies in opioid analgesia within the Czech prehospital emergency system.