Intranasal sufentanil vs intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study
PLoS Medicine Jul 22, 2019
Blancher M, et al. - Via a prospective, randomized, multicenter non-inferiority trial carried out in the emergency departments of 6 hospitals in France from November 4, 2013, and April 10, 2016, the researchers discovered whether intranasal (IN) sufentanil (INS) for 194 subjects presenting to an emergency department with acute severe traumatic pain (most prevalent symptom presented by cases in hospital emergency departments, particularly in the context of trauma) leads to a decrease in pain intensity non-inferior to intravenous morphine (IVM). Individuals were categorized 1:1 to INS titration and intravenous placebo, or to IVM and IN placebo groups. Non-inferiority was exhibited, as the lower 97.5% confidence interval of 0.29 was above the prespecified margin of −1.3. However, without a clinically important variation in mean NRS among groups, INS was observed to be better than IVM. In the INS group, 6 severe adverse events were noted and in the IVM group, two including an apparent imbalance for hypoxemia and for bradypnea were observed. The choice of concomitant analgesics, when they were practiced, was left to the discretion of the physician in charge, and co-analgesia was more regularly used in the IVM group, which was the chief limitation of the study, along with the size of the study which did not support to decide with certainty about the safety of INS in emergency settings. Hence, in patients with severe traumatic pain presenting to an emergency department, the non-inferiority of INS vs IVM for pain decrease at 30 minutes following administration was concluded. In difficult situations and in emergency settings, the IN route, with no requirement to get a venous route, may enable early and efficient analgesia. Further larger studies to verify the safety profile of INS would be needed.
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