Larger studies needed to further assess safety of intranasal sufentanil
WEDNESDAY, July 17, 2019 (HealthDay News) — Intranasal sufentanil (INS) is comparable to intravenous morphine (IVM) for acute severe trauma pain treated in the emergency department, according to a study published online July 16 in PLOS Medicine.
Marc Blancher, M.D., from Grenoble Alpes University Hospital in France, and colleagues randomly assigned 157 emergency department patients with acute severe traumatic pain (1:1) to either INS titration (0.3 µg/kg and additional doses of 0.15 µg/kg at 10 minutes and 20 minutes if numerical pain rating scale [NRS] >3) and intravenous placebo or to IVM (0.1 mg/kg and additional doses of 0.05 mg/kg at 10 minutes and 20 minutes if NRS >3) and intranasal (IN) placebo.
The researchers found a mean difference between NRS at first administration and NRS at 30 minutes of −4.1 (97.5 percent confidence interval, −4.6 to −3.6) in the IVM group and −5.2 (97.5 percent confidence interval, −5.7 to −4.6) in the INS group. This finding demonstrated noninferiority (P < 0.001) because the lower 97.5 percent confidence interval (0.29 to 1.93) was greater than the prespecified margin of −1.3. Although there was no clinically significant difference in mean NRS between the groups, INS was superior to IVM (intention to treat analysis, P = 0.034). There were six severe adverse events in the INS group versus two in the IVM group, including more hypoxemia (three in the INS group versus one in the IVM group) and bradypnea (two and zero, respectively).
“The IN route, with no need to obtain a venous route, may allow early and effective analgesia in emergency settings and in difficult situations,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.
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