Pooled Dosing and Efficacy Analysis of the Sufentanil Sublingual Tablet 30 mcg Across Demographic Subgroups for the Management of Moderate-to-Severe Acute Pain

Jacob L. Hutchins; David Leiman; Zubaid Rafique; Karen P. DiDonato; Pamela P. Palmer

doi:10.1016/j.jopan.2019.08.009

Pooled Dosing and Efficacy Analysis of the Sufentanil Sublingual Tablet 30 mcg Across Demographic Subgroups for the Management of Moderate-to-Severe Acute Pain

Jacob L. Hutchins, David Leiman, Zubaid Rafique, Karen P. DiDonato, Pamela P. Palmer

Anesthesiology

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

Abstract

Purpose: To aid nurses in dosing sufentanil sublingual tablet (SST) 30 mcg administered via a single-dose applicator, dosing requirements and efficacy of SST 30 mcg were analyzed across age, sex, race, and body mass index subgroups. Design: Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study. Drug dosing and efficacy data were pooled from the postoperative studies. Methods: Efficacy was assessed through summed pain intensity difference to baseline during 12 hours across subgroups. Findings: Mean (standard deviation) drug doses administered from 0 to 12 hours was 3.9 (2.0) for SST 30 mcg and was less frequent for older (≥65 years) versus younger patients. The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. Conclusions: SST 30 mcg is a sublingual opioid analgesic with efficacy across demographic subgroups.

Original language	English (US)
Pages (from-to)	22-28
Number of pages	7
Journal	Journal of Perianesthesia Nursing
Volume	35
Issue number	1
DOIs	https://doi.org/10.1016/j.jopan.2019.08.009
State	Published - Feb 2020

Bibliographical note

Funding Information:
Funding: These studies were funded by AcelRx Pharmaceuticals. Three of the studies were also funded by the Clinical and Rehabilitative Medicine Research Program of the US Army Medical Research and Materiel Command under contract nos. W81XWH-15-C-0046 (SAP302 and SAP303) and W81XWH-11-1-0361 (SAP202).Editorial assistance, including literature review and drafting and copy editing the manuscript, was provided by Rob Steger and Penny Baron (Ashfield Healthcare Communications, a UDG Healthcare plc company), New York, USA, and funded by AcelRx Pharmaceuticals. Statistical analysis was provided by Yu-Kun Chiang, PhD (statistical consultant for AcelRx).

Publisher Copyright:
© 2019 The Authors

Keywords

acute pain
analgesia
opioid
sublingual

Publisher link

10.1016/j.jopan.2019.08.009

Find It

Find It at U of M Libraries

Cite this

@article{a1bf2ee0badf4679a2994d8b9626e11e,

title = "Pooled Dosing and Efficacy Analysis of the Sufentanil Sublingual Tablet 30 mcg Across Demographic Subgroups for the Management of Moderate-to-Severe Acute Pain",

abstract = "Purpose: To aid nurses in dosing sufentanil sublingual tablet (SST) 30 mcg administered via a single-dose applicator, dosing requirements and efficacy of SST 30 mcg were analyzed across age, sex, race, and body mass index subgroups. Design: Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study. Drug dosing and efficacy data were pooled from the postoperative studies. Methods: Efficacy was assessed through summed pain intensity difference to baseline during 12 hours across subgroups. Findings: Mean (standard deviation) drug doses administered from 0 to 12 hours was 3.9 (2.0) for SST 30 mcg and was less frequent for older (≥65 years) versus younger patients. The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. Conclusions: SST 30 mcg is a sublingual opioid analgesic with efficacy across demographic subgroups.",

keywords = "acute pain, analgesia, opioid, sublingual",

author = "Hutchins, {Jacob L.} and David Leiman and Zubaid Rafique and DiDonato, {Karen P.} and Palmer, {Pamela P.}",

note = "Funding Information: Funding: These studies were funded by AcelRx Pharmaceuticals. Three of the studies were also funded by the Clinical and Rehabilitative Medicine Research Program of the US Army Medical Research and Materiel Command under contract nos. W81XWH-15-C-0046 (SAP302 and SAP303) and W81XWH-11-1-0361 (SAP202).Editorial assistance, including literature review and drafting and copy editing the manuscript, was provided by Rob Steger and Penny Baron (Ashfield Healthcare Communications, a UDG Healthcare plc company), New York, USA, and funded by AcelRx Pharmaceuticals. Statistical analysis was provided by Yu-Kun Chiang, PhD (statistical consultant for AcelRx). Publisher Copyright: {\textcopyright} 2019 The Authors",

year = "2020",

month = feb,

doi = "10.1016/j.jopan.2019.08.009",

language = "English (US)",

volume = "35",

pages = "22--28",

journal = "Journal of Perianesthesia Nursing",

issn = "1089-9472",

publisher = "W.B. Saunders",

number = "1",

}

TY - JOUR

T1 - Pooled Dosing and Efficacy Analysis of the Sufentanil Sublingual Tablet 30 mcg Across Demographic Subgroups for the Management of Moderate-to-Severe Acute Pain

AU - Hutchins, Jacob L.

AU - Leiman, David

AU - Rafique, Zubaid

AU - DiDonato, Karen P.

AU - Palmer, Pamela P.

N1 - Funding Information: Funding: These studies were funded by AcelRx Pharmaceuticals. Three of the studies were also funded by the Clinical and Rehabilitative Medicine Research Program of the US Army Medical Research and Materiel Command under contract nos. W81XWH-15-C-0046 (SAP302 and SAP303) and W81XWH-11-1-0361 (SAP202).Editorial assistance, including literature review and drafting and copy editing the manuscript, was provided by Rob Steger and Penny Baron (Ashfield Healthcare Communications, a UDG Healthcare plc company), New York, USA, and funded by AcelRx Pharmaceuticals. Statistical analysis was provided by Yu-Kun Chiang, PhD (statistical consultant for AcelRx). Publisher Copyright: © 2019 The Authors

PY - 2020/2

Y1 - 2020/2

N2 - Purpose: To aid nurses in dosing sufentanil sublingual tablet (SST) 30 mcg administered via a single-dose applicator, dosing requirements and efficacy of SST 30 mcg were analyzed across age, sex, race, and body mass index subgroups. Design: Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study. Drug dosing and efficacy data were pooled from the postoperative studies. Methods: Efficacy was assessed through summed pain intensity difference to baseline during 12 hours across subgroups. Findings: Mean (standard deviation) drug doses administered from 0 to 12 hours was 3.9 (2.0) for SST 30 mcg and was less frequent for older (≥65 years) versus younger patients. The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. Conclusions: SST 30 mcg is a sublingual opioid analgesic with efficacy across demographic subgroups.

AB - Purpose: To aid nurses in dosing sufentanil sublingual tablet (SST) 30 mcg administered via a single-dose applicator, dosing requirements and efficacy of SST 30 mcg were analyzed across age, sex, race, and body mass index subgroups. Design: Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study. Drug dosing and efficacy data were pooled from the postoperative studies. Methods: Efficacy was assessed through summed pain intensity difference to baseline during 12 hours across subgroups. Findings: Mean (standard deviation) drug doses administered from 0 to 12 hours was 3.9 (2.0) for SST 30 mcg and was less frequent for older (≥65 years) versus younger patients. The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. Conclusions: SST 30 mcg is a sublingual opioid analgesic with efficacy across demographic subgroups.

KW - acute pain

KW - analgesia

KW - opioid

KW - sublingual

UR - http://www.scopus.com/inward/record.url?scp=85075335176&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85075335176&partnerID=8YFLogxK

U2 - 10.1016/j.jopan.2019.08.009

DO - 10.1016/j.jopan.2019.08.009

M3 - Article

C2 - 31732448

AN - SCOPUS:85075335176

SN - 1089-9472

VL - 35

SP - 22

EP - 28

JO - Journal of Perianesthesia Nursing

JF - Journal of Perianesthesia Nursing

IS - 1

ER -

Pooled Dosing and Efficacy Analysis of the Sufentanil Sublingual Tablet 30 mcg Across Demographic Subgroups for the Management of Moderate-to-Severe Acute Pain

Abstract

Bibliographical note

Keywords

Publisher link

Find It

Other files and links

Fingerprint

Cite this