Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, United States.
Department of Emergency Medicine, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX, United States.
Am J Emerg Med. 2018 Jun;36(6):954-961. doi: 10.1016/j.ajem.2017.10.058. Epub 2017 Oct 31.
Pharmacological properties of the sufentanil sublingual tablet 30mcg (SST 30mcg) could offer potential analgesic advantages in settings requiring noninvasive, acute pain management. The feasibility of using SST 30mcg for moderate-to-severe pain management in the emergency department (ED) was evaluated.
This open-label, multicenter feasibility study included patients aged ≥18years who presented to the ED with moderate-to-severe pain (≥4 on the numeric rating scale of pain intensity (NRS); opioid-tolerant patients were excluded. Patients received a single SST 30-mcg dose (single-dose cohort) or, upon request, ≤3 additional doses ≥60min apart (multiple-dose cohort) and were evaluated over 1 or 2h. Effectiveness was assessed by patient-reported pain scores (11-point NRS; 5-point pain relief scale). Safety and tolerability were also assessed.
Overall, 76 patients enrolled into the single-dose (n=40) and multiple-dose (n=36) cohorts. In the first hour (combined cohorts), mean pain intensity was significantly lower 15-min post-dosing (P<0.001; clinically meaningful within 30-minutes post-dosing) and continued to decrease during the first hour (P<0.001 for each 15-minute interval). Mean pain intensity (multiple-dose cohort) decreased from 7.6 at baseline to 4.5 at 1h and to 4.6 at 2h (P<0.001 for both); mean pain relief increased from baseline to 1.9 at 1h (P<0.001) and to 2.0 at 2h (P<0.001). Most (79%) patients had no adverse events (AEs), and there were no severe AEs.
SST 30mcg was feasible for managing moderate-to-severe acute pain in an ED setting.
舒芬太尼舌下片 30mcg（SST 30mcg）的药理学特性可能为需要非侵入性急性疼痛管理的环境提供潜在的镇痛优势。评估 SST 30mcg 在急诊科（ED）中用于中重度疼痛管理的可行性。
这项开放标签、多中心可行性研究纳入了年龄≥18 岁的患者，这些患者因中重度疼痛（疼痛强度数字评分量表（NRS）≥4；排除阿片类药物耐受患者）到 ED 就诊。患者接受单次 SST 30-mcg 剂量（单次剂量队列）或按需在 60 分钟以上接受≤3 次额外剂量（多次剂量队列），并在 1 或 2 小时内进行评估。通过患者报告的疼痛评分（11 点 NRS；5 分疼痛缓解量表）评估有效性。还评估了安全性和耐受性。
总体而言，76 例患者入组单次剂量（n=40）和多次剂量（n=36）队列。在第一个小时（联合队列）中，15 分钟后（P<0.001；在 30 分钟内具有临床意义）和整个第一个小时（在每个 15 分钟间隔内，P<0.001）的平均疼痛强度显著降低。（多次剂量队列）从基线的 7.6 降至 1 小时时的 4.5，再降至 2 小时时的 4.6（均 P<0.001）；平均疼痛缓解从基线时的 1.9 增加到 1 小时（P<0.001），再增加到 2 小时（P<0.001）。大多数（79%）患者无不良事件（AE），无严重 AE。
SST 30mcg 可用于 ED 环境中管理中重度急性疼痛。
