Sufentanil sublingual tablet 30mcg for moderate-to-severe acute pain in the ED.

Abstract

BACKGROUND:

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.

METHODS:

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.

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 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.

CONCLUSIONS:

SST 30mcg was feasible for managing moderate-to-severe acute pain in an ED setting.

• Authors: James R Miner, Zubaid Rafique, Harold S Minkowitz, Karen P DiDonato, Pamela P Palmer
• Journal: The American journal of emergency medicine (Am J Emerg Med) Vol. 36 Issue 6 Pg. 954-961 (Jun 2018) ISSN: 1532-8171 [Electronic] United States
• PMID: 29122372 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Analgesics, Opioid
• Tablets
• Sufentanil

Topics

• Acute Pain (diagnosis, drug therapy)
• Administration, Sublingual
• Aged
• Analgesics, Opioid (administration & dosage)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Emergency Service, Hospital
• Feasibility Studies
• Female
• Humans
• Male
• Pain Management (methods)
• Pain Measurement
• Severity of Illness Index
• Sufentanil (administration & dosage)
• Tablets
• Treatment Outcome