A Randomized Controlled Trial of Sublingual Sufentanil in Early Management of Pain in Trauma.

Background: Pain management is essential in trauma. Sufentanil is a potent sublingual opioid analgesic with no active metabolites and rapid onset relative to oral medications. We hypothesize that compared to standard care, Sufentanil reduces the verbally administered numerical pain scale (VNRS) at 30 minutes.

Methods: We performed a prospective multicenter, open-label, randomized trial utilizing level-1 trauma centers from within the Linking Investigator in Trauma and Emergency Services (LITES) network. Participants were randomly assigned in a 1:1 ratio to either sublingual sufentanil or standard care. We enrolled 150 patients from July 2022 to January 2024. The study was approved by the human subjects research protection offices of the University of Pittsburgh and the Department of Defense. Subjects were eligible if they had a trauma evaluation, were 18 to 70, had a VNRS (0-100) score ≥50, and remained in the ED for at least 30 minutes. We excluded patients who were prisoners, pregnant, allergic to opioids, required airway management, body mass index (BMI) >40, significant respiratory depression, suspected gastrointestinal obstruction, or other contraindication to analgesics. The primary outcome was the VNRS for clinical pain measurement (0-100) at 30 minutes after treatment. Secondary outcomes included adverse events (hypoxia, hypotension, need for airway management) and the incidence of nausea/vomiting/headache/dizziness requiring treatment. We hypothesize that sublingual sufentanil as compared to emergency department standard care, will reduce the VNRS at 30 minutes.

Results: The study population had a mean age of 48 years (standard deviation [SD] 15) and was 32% female. The mechanism of injury was mostly blunt (96%). The VNRS at 30 minutes was 67 (SD 25) for the entire cohort, 66 (SD 23) in the sufentanil group, and 68 (SD 27) in the standard care group ( P = .37). The Health care Professional Global Assessment (HPGA) at 30 minutes showed decreased pain scores in the standard care group compared to sufentanil, with standard care having more patients scored as good or excellent ( P = .009). There was no difference in the incidence of nausea, vomiting, headache, dizziness, hypoxia, hypotension, or need for an advanced airway.

Conclusions: In this cohort of trauma patients with moderate to severe pain, the VNRS at 30 minutes after administration of analgesics did not differ between sublingual sufentanil and standard care. Adverse events did not differ between the groups suggesting the sublingual sufentanil in this population.