Background: Pharmacological properties of the sufentanil sublingual tablet 30 mcg (SST 30 mcg) could offer potential analgesic advantages in settings requiring noninvasive, acute pain management. The feasibility of using SST 30 mcg for moderate-to-severe pain management in the emergency department (ED) was evaluated. Methods: This open-label, multicenter feasibility study included patients aged ≥ 18 years 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 ≥ 60 min apart (multiple-dose cohort) and were evaluated over 1 or 2 h. Effectiveness was assessed by patient-reported pain scores (11-point NRS; 5-point pain relief scale). Safety and tolerability were also assessed. Results: 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 1 h and to 4.6 at 2 h (P < 0.001 for both); mean pain relief increased from baseline to 1.9 at 1 h (P < 0.001) and to 2.0 at 2 h (P < 0.001). Most (79%) patients had no adverse events (AEs), and there were no severe AEs. Conclusions: SST 30 mcg was feasible for managing moderate-to-severe acute pain in an ED setting.
Bibliographical noteFunding Information:
The authors would like to thank the research team at Research Concepts GP, LLC (Bellaire, Texas) for all their hard work during the conduct of this study. Editorial assistance was provided by BlueMomentum (a division of Ashfield Healthcare Communications, a UDG Healthcare plc company), San Bruno, California, USA, and funded by AcelRx Pharmaceuticals.
This study was funded by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the United States Army Medical Research and Materiel Command ( USAMRMC ) under contract No. W81XWH-15-C-0046 .
© 2017 The Authors
- Acute pain
- Administration, oral
- Analgesics, opioid
- Clinical trial
- Emergency service, hospital