PMID- 29122372 OWN - NLM STAT- MEDLINE DCOM- 20190503 LR - 20190503 IS - 1532-8171 (Electronic) IS - 0735-6757 (Linking) VI - 36 IP - 6 DP - 2018 Jun TI - Sufentanil sublingual tablet 30mcg for moderate-to-severe acute pain in the ED. PG - 954-961 LID - S0735-6757(17)30886-0 [pii] LID - 10.1016/j.ajem.2017.10.058 [doi] AB - 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, /=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. CI - Copyright (c) 2017 The Authors. Published by Elsevier Inc. All rights reserved. FAU - Miner, James R AU - Miner JR AD - Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, United States. Electronic address: James.Miner@hcmed.org. FAU - Rafique, Zubaid AU - Rafique Z AD - Department of Emergency Medicine, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX, United States. Electronic address: zubaidrafique@gmail.com. FAU - Minkowitz, Harold S AU - Minkowitz HS AD - Department of Anesthesiology, Memorial Hermann-Memorial City Medical Center, Houston, TX, United States. Electronic address: harold@minkowitzmd.com. FAU - DiDonato, Karen P AU - DiDonato KP AD - Department of Medical and Clinical Affairs, AcelRx Pharmaceuticals, Redwood City, CA, United States. Electronic address: kdidonato@acelrx.com. FAU - Palmer, Pamela P AU - Palmer PP AD - Department of Medical and Clinical Affairs, AcelRx Pharmaceuticals, Redwood City, CA, United States. Electronic address: ppalmer@acelrx.com. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20171031 PL - United States TA - Am J Emerg Med JT - The American journal of emergency medicine JID - 8309942 RN - 0 (Analgesics, Opioid) RN - 0 (Tablets) RN - AFE2YW0IIZ (Sufentanil) SB - IM MH - Acute Pain/diagnosis/*drug therapy MH - Administration, Sublingual MH - Aged MH - Analgesics, Opioid/administration & dosage MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - *Emergency Service, Hospital MH - Feasibility Studies MH - Female MH - Humans MH - Male MH - Pain Management/*methods MH - Pain Measurement MH - Severity of Illness Index MH - Sufentanil/*administration & dosage MH - Tablets MH - Treatment Outcome OTO - NOTNLM OT - Acute pain OT - Administration, oral OT - Analgesics, opioid OT - Clinical trial OT - Emergency service, hospital EDAT- 2017/11/11 06:00 MHDA- 2019/05/06 06:00 CRDT- 2017/11/11 06:00 PHST- 2017/03/22 00:00 [received] PHST- 2017/10/24 00:00 [revised] PHST- 2017/10/25 00:00 [accepted] PHST- 2017/11/11 06:00 [pubmed] PHST- 2019/05/06 06:00 [medline] PHST- 2017/11/11 06:00 [entrez] AID - S0735-6757(17)30886-0 [pii] AID - 10.1016/j.ajem.2017.10.058 [doi] PST - ppublish SO - Am J Emerg Med. 2018 Jun;36(6):954-961. doi: 10.1016/j.ajem.2017.10.058. Epub 2017 Oct 31.