RESUMO
BACKGROUND: Intranasal sufentanil is a potent opioid which can be used in patients with traumatic injuries presenting to the ED. Although previous studies have demonstrated the superiority of intranasal sufentanil over intravenous morphine in terms of pain relief, its clinical superiority in patients with traumatic injuries receiving adequate multimodal analgesia with acetaminophen and non-steroidal anti-inflammatory drugs is uncertain. We compared pain relief offered by intranasal sufentanil with that offered by oral and intravenous opioids in patients with acute traumatic injuries also receiving a specified regimen of non-opioid treatment. METHODS: In this single-centre, open-label, parallel-group, randomised controlled superiority trial conducted between January 2020 and February 2022, trauma patients presenting to the ED with a pain score of ≥7 on a visual analogue scale (VAS) were randomised to receive either intranasal sufentanil or other oral/intravenous opioids alongside oral/intravenous acetaminophen and non-steroidal anti-inflammatory drugs. The primary outcome was reduction in VAS score 15-20 min after randomisation. RESULTS: An intention-to-treat analysis included 170 out of 205 patients screened for inclusion. The intranasal sufentanil group (83 patients) showed a significantly greater reduction in pain when compared with the oral/intravenous opioid group (87 patients) 15-20 min after randomisation (reduction in VAS score 3.0 (IQR 1.7-5.0) vs 1.5 (IQR 0.9-3.0); p<0.001). Similarly, a greater reduction in pain was observed in the intranasal sufentanil group 60 min after randomisation (5.0 (IQR 3.0-7.0) vs 3.0 (IQR 2.0-5.3); p<0.001). However, side effects were more frequent in the intervention group (71.1% vs 23%; p<0.001). CONCLUSIONS: Intranasal sufentanil was associated with more effective pain relief than oral/intravenous opioids in patients with traumatic injuries treated with coanalgesia. Intranasal sufentanil could be considered for the management of pain in patients with traumatic injuries associated with severe pain. TRIAL REGISTRATION NUMBER: NCT04137198.
