Intranasal sufentanil given in the emergency department triage zone for severe acute traumatic pain: a randomized double-blind controlled trial

Lemoël, Fabien; Contenti, Julie; Cibiera, Charles; Rapp, Jocelyn; Occelli, Céline; Levraut, J.

doi:10.1007/s11739-018-02014-y

Cited by 19 publications

(9 citation statements)

References 18 publications

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“…Some adverse effects were reported, such as dysphoria (46.6%), nausea (13.3%), and dizziness (7.5%), but no apnea was observed. More recently 2 monocentric randomized controlled trials versus placebo have been published [16–17]. Lemoel et al [16] administered a single dose of 0.4 μg/kg of INS (or placebo) to 144 patients admitted to the emergency department for a recent (<6 h) isolated limb injury.…”

Section: Discussionmentioning

confidence: 99%

“…More recently 2 monocentric randomized controlled trials versus placebo have been published [16–17]. Lemoel et al [16] administered a single dose of 0.4 μg/kg of INS (or placebo) to 144 patients admitted to the emergency department for a recent (<6 h) isolated limb injury. Usual IV pain treatment was given to every patient, with multimodal analgesics including IV opioids if needed.…”

Section: Discussionmentioning

confidence: 99%

“…Apart from non-randomized and open-label studies [14,15], 2 recent studies evaluated IN sufentanil (INS) in good methodological conditions. Lemoel et al [16] compared INS to venous analgesia but without a standardized comparator: the venous analgesia did not systematically include an opiate. Sin et al [17] performed a low-powered study (30 patients) and showed no difference in analgesia, but the study was not designed to prove non-inferiority.…”

Section: Introductionmentioning

confidence: 99%

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Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study

et al. 2019

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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...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study

et al. 2019

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“…Several randomized studies have compared IN sufentanil with intravenous (IV) morphine for acute pain control in emergency departments. At doses of 0.7 µg/kg (21) or 0.4 µg/kg (22), IN sufentanil provides rapid, reliable and effective pain control, comparable with that of IV morphine. IN sufentanil titration is possible with an initial bolus dose of 0.3 µg/kg, then 0.15 µg/kg at 10 minutes and again at 20 minutes (if the NRS 3) (23).…”

Section: Introductionmentioning

confidence: 99%

Use of Intranasal Analgesia in Military Setting: a French Cross Sectional Survey

Montagnon¹,

Cungi²,

Morand³

et al. 2021

Preprint

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Background For military physicians, practice in tactical and austere environments, particularly during deployments, requires optimized pain management. Several recent studies have shown a definite interest in the intranasal (IN) route for analgesia. Few published series show efficacy and variable times of action depending on the drug used (ketamine, sufentanil and fentanyl), with exceptional side effects. The aim of this study is to evaluate the medical practice of the French Military Health Service (FMHS) physicians.Methods We carried out a declarative and multicentric survey from January 15, 2020, to April 14, 2020. The surveyed population was the physicians of the FMHS, 727 working in medical units and 55 in emergency departments (EDs) in France and overseas. Results In all, 259 responses were collected, giving a 33% return rate; 77.6% of physicians reported being familiar with the IN route for analgesia. However, only 18.4% had already used it. Physicians trained in emergency medicine and assigned to highly operational units were more familiar with this route and used it more frequently. The most common drug used was ketamine (51%). Finally, 90% of respondents expressed an interest in training and use of intranasal analgesia. ConclusionsIf a majority of physicians from the FMHS are familiar with IN analgesia, only few use it in practice. Therefore, specific training is suitable to improve this knowledge and homogenize guidelines. Having been the subject of numerous studies in progress in civilian and military medicine, the IN route seems to be a promising solution for remote and austere environments.

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“…15 Several studies have demonstrated the efficacy and good tolerance of intranasal fentanyl administration in children for acute pain in the ED, [16][17][18][19][20] and other trials have found IN sufentanil to be safe and effective in adults in the ED. [21][22][23][24][25][26] Previous small-scale randomized trials comparing IN sufentanil to IV morphine showed encouraging results, ranging from no difference between the two treatments 23,24 to non-inferior results. 25 Another randomized study found better and faster pain relief with IN sufentanil compared to a multimodal IV strategy.…”

Section: Introductionmentioning

confidence: 99%

Intranasal sufentanil compared with a classic protocol for acute pain management in an emergency department: A prospective sequential study

Kreps

Malinverni

Carles

et al. 2021

Trauma

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Introduction Pain is a frequent complaint in the emergency department and should be measured and treated according to the existing protocols. The intranasal route offers several advantages over the oral or intravenous routes. The aim of the study was to evaluate the efficacy and safety of intranasal sufentanil as the primary opioid for acute pain in the emergency department. Materials and methods This was a prospective open-label sequential study in patients who presented to the emergency department with severe non-visceral pain. The control group was treated according to the current standard of care including oral or intravenous opioids whereas the intervention group was treated according to a modified protocol, including intranasal sufentanil as the only opioid. Pain intensity was measured at different time points. The occurrence of side effects, the placement of intravenous lines and the need for additional analgesia were also recorded. Results Pain intensity in the two groups was not comparable at baseline (8.5; IQR 8–10 in the intervention group vs 7.9; IQR 7–9.4 in the control group; p = .026). However, the median reduction of the pain score was significantly larger in the intervention group compared to the control group after 15 minutes (2.5; IQR 1.2 – 4 vs 1.6; IQR 1–2.4; p = .005) and after 30 min (4; IQR 3–5.7 vs 3.1; IQR 2–4.4; p = .02). No significant difference in pain scores between the two groups was observed after 60 min from baseline. Conclusions Patients receiving intranasal sufentanil for severe pain achieved better pain relief at 15 min and 30 min compared to those receiving standard care. Vertigo, nausea, vomiting and diaphoresis were side effects more frequently observed in the sufentanil group. No differences in pain relief were observed after 30 and 60 min from baseline.

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Intranasal sufentanil given in the emergency department triage zone for severe acute traumatic pain: a randomized double-blind controlled trial

Cited by 19 publications

References 18 publications

Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study

Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study

Use of Intranasal Analgesia in Military Setting: a French Cross Sectional Survey

Intranasal sufentanil compared with a classic protocol for acute pain management in an emergency department: A prospective sequential study

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