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
- pain management
Data availability statement
Data are available in a public, open access repository. Data are available at the following address: https://doi.org/10.6084/m9.figshare.22348558.v1.
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Handling editor Jason E Smith
Contributors SM contributed substantially to the conception and design of the study; to the acquisition, analysis and interpretation of the data. SM drafted the manuscript and approved the final version, which has been submitted for publication. PYT contributed substantially to the design of the study and the acquisition and interpretation of the data. TL contributed substantially to data acquisition and interpretation. F-ZB contributed substantially to the data analysis and interpretation. APl and APa contributed significantly to data acquisition and interpretation. MB contributed substantially to the data interpretation. BK substantially contributed to the conception and design of the study as well as the acquisition and interpretation of the data. PYT, TL, F-ZB, APl, APa, MB and BK critically revised and approved the final version of the manuscript for publication. SM is the garantor of the study, accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.
Funding This study was supported by an unconditional grant from the Association d'Aide à la Recherche Médicale André Vésale.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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