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Intranasal sufentanil as effective as intravenous morphine for acute pain
France: Intranasal sufentanil (INS) is non-inferior to the most commonly used strong analgesic intravenous morphine (IVM) for the treatment of acute severe trauma pain in the emergency department, according to a recent study published in the journal PLOS Medicine.
IVM is the most common strong analgesic used in trauma but the need to obtain intravenous access is a clear limitation to its rapid use. The intranasal (IN) route provides easy administration with a fast peak action time due to high vascularization and the absence of the first-pass metabolism.
The prospective, randomized, multicenter non-inferiority trial was conducted in the emergency departments of 6 hospitals across France. The researchers assigned the 157 emergency department patients with acute severe traumatic pain to 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 IN placebo in the ratio 1:1.
Key findings of the study include:
- The mean difference between NRS at first administration and NRS at 30 minutes was −4.1 in the IVM group and −5.2 in the INS group.
- Non-inferiority was demonstrated, as the lower 97.5% confidence interval of 0.29 was above the prespecified margin of −1.3. INS was superior to IVM but without a clinically significant difference in mean NRS between groups.
- Six severe adverse events were observed in the INS group and 2 in the IVM group (number needed to harm: 17), including an apparent imbalance for hypoxemia (3 in the INS group versus 1 in the IVM group) and for bradypnea (2 in the INS group versus 0 in the IVM group).
"The IN route, with no need to obtain a venous route, may allow early and effective analgesia in emergency settings and in difficult situations. Confirmation of the safety profile of INS will require further larger studies," concluded the authors.
To read the complete study follow the link: https://doi.org/10.1371/journal.pmed.1002849
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