Evidence map›Paper›PMID 25318408›Full record

Trial reportRegional anesthesia and pain medicine

Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study.

Forrest G Ringold, Harold S Minkowitz, Tong Joo Gan, Keith A Aqua, Yu-Kun Chiang, Mark A Evashenk, Pamela P Palmer

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Regional anesthesia and pain medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
6.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01539642 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery

TypeinterventionalSponsorTalphera, IncRan2012 to 2013Enrolled172ConditionsPost-Operative PainArmsSufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System
NCT04716413 phase4terminatednot on this map

Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Who Are Undergoing Ambulatory Surgery- a Case Series

TypeinterventionalSponsorMontefiore Medical CenterRan2021 to 2022Enrolled3ConditionsAcute PainArmsDsuvia
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. Pooled it
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  13. Epidural and Non-epidural Analgesia in Patients Undergoing Open Pancreatectomy: a Retrospective Cohort Study.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2019
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  16. New Advances in Acute Postoperative Pain Management.Current pain and headache reports · 2018
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 2 countries.

Forrest G RingoldFrom the *Mobile Infirmary Medical Center, Mobile, AL; †Memorial Hermann-Memorial City Medical Center, Houston, TX; ‡Duke University Medical Center, Durham, NC; §Visions Clinical Research, Boyton Beach, FL; ║Essence Sciences, San Jose, CA; and **AcelRx Pharmaceuticals, Redwood City, CA.
Harold S Minkowitz
Tong Joo Gan
Keith A Aqua
Yu-Kun Chiang
Mark A Evashenk
Pamela P Palmer
AcelRx Pharmaceuticals (United States) · USDuke Medical Center · USEssence Line (Czechia) · CZMemorial Hermann Memorial City Medical Center · USMobile Infirmary · USSelect Engineering Services (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThis study evaluates the efficacy and safety of a sufentanil sublingual tablet system (SSTS) for the management of postoperative pain following open abdominal surgery.

methodsAt 13 hospital sites in the United States, patients following surgery with pain intensity of greater than 4 on an 11-point numerical rating scale were randomized to receive SSTS dispensing a 15-μg sufentanil tablet sublingually with a 20-minute lockout or an identical system dispensing a placebo tablet sublingually. Pain intensity scores were recorded at baseline and for up to 72 hours after starting study drug. The primary end point was time-weighted summed pain intensity difference (SPID) over 48 hours. Secondary end points included SPID and total pain relief (TOTPAR) for up to 72 hours and patient and health care provider global assessments of the method of pain control.

resultsSummed pain intensity difference over 48 hours was significantly higher in the SSTS group than in the placebo group (least squares mean [SEM], 105.60 [10.14] vs 55.58 [13.11]; P = 0.001). Mean SPID and TOTPAR scores were significantly higher in the SSTS group at all time points from 1 hour (SPID) or 2 hours (TOTPAR) until 72 hours (P < 0.05). In the SSTS group, patient global assessment and health care provider global assessment ratings of good or excellent were greater than placebo at all time points (P < 0.01). Safety parameters, including adverse events and vital signs, were similar for SSTS and placebo.

conclusionsThese results suggest that SSTS is effective and safe for the management of postoperative pain in patients following open abdominal surgery.

Indexed as

AbdomenAdministration, SublingualAdultAgedAged, 80 and overAnalgesia, Patient-ControlledAnalgesics, OpioidDigestive System Surgical ProceduresDouble-Blind MethodFemaleHumansMaleMiddle AgedPain ManagementPostoperative PainSufentanilAnalgesics, OpioidSufentanilTablets

Identifiers

PMID25318408
PMCPMC4272222
OpenAlexW2030038708

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.