Background
Intravenous morphine (IVM) is the most common strong analgesic used in trauma, but is associated with a clear time limitation related to the need to obtain an access route. The intranasal (IN) route provides easy administration with a fast peak action time due to high vascularization and the absence of first-pass metabolism. We aimed to determine whether IN sufentanil (INS) for patients presenting to an emergency department with acute severe traumatic pain results in a reduction in pain intensity non-inferior to IVM.
Methods and findings
In a prospective, randomized, multicenter non-inferiority trial conducted in the emergency departments of 6 hospitals across France, patients were randomized 1:1 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. Patients, clinical staff, and research staff were blinded to the treatment allocation. The primary endpoint was the total decrease on NRS at 30 minutes after first administration. The prespecified non-inferiority margin was −1.3 on the NRS. The primary outcome was analyzed per protocol. Adverse events were prospectively recorded during 4 hours. Among the 194 patients enrolled in the emergency department cohort between November 4, 2013, and April 10, 2016, 157 were randomized, and the protocol was correctly administered in 136 (69 IVM group, 67 INS group, per protocol population, 76% men, median age 40 [IQR 29 to 54] years). The mean difference between NRS at first administration and NRS at 30 minutes was −4.1 (97.5% CI −4.6 to −3.6) in the IVM group and −5.2 (97.5% CI −5.7 to −4.6) in the INS group. Non-inferiority was demonstrated (
p <
0.001 with 1-sided mean-equivalence
t
test), as the lower 97.5% confidence interval of 0.29 (97.5% CI 0.29 to 1.93) was above the prespecified margin of −1.3. INS was superior to IVM (intention to treat analysis:
p =
0.034), 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 main limitation of the study was that the choice of concomitant analgesics, when they were used, was left to the discretion of the physician in charge, and co-analgesia was more often used in the IVM group. Moreover, the size of the study did not allow us to conclude with certainty about the safety of INS in emergency settings.
Conclusions
We confirm the non-inferiority of INS compared to IVM for pain reduction at 30 minutes after administration in patients with severe traumatic pain presentin...
Summary
There is increasing evidence that a minority of adults with acute appendicitis have gastric contents, posing an increased risk of pulmonary aspiration. This study aimed to evaluate the proportion of children with acute appendicitis who have gastric contents considered to pose a higher risk of pulmonary aspiration. We analysed point‐of‐care gastric ultrasound data routinely collected in children before emergency appendicectomy in a specialist paediatric hospital over a 30‐month period. Based on qualitative and quantitative antral assessment in the supine and right lateral decubitus positions, gastric contents were classified as ‘higher‐risk’ (clear liquid with calculated gastric fluid volume > 0.8 ml.kg−1, thick liquid or solid) or ‘lower‐risk’ of pulmonary aspiration. The 115 children studied had a mean (SD) age of 11 (3) years; 37 (32%; 95%CI: 24–42%) presented with higher‐risk gastric contents, including 15 (13%; 95%CI: 8–21%) with solid/thick liquid contents. Gastric contents could not be determined in 13 children as ultrasound examination was not feasible in the right lateral decubitus position. No cases of pulmonary aspiration occurred. This study shows that gastric ultrasound is feasible in children before emergency appendicectomy. This technique showed a range of gastric content measurements, which could contribute towards defining the risk of pulmonary aspiration.
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