Evidence map›Paper›PMID 25155134›Full record

Trial reportPain practice : the official journal of World Institute of Pain2014

Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial.

Timothy I Melson, David L Boyer, Harold S Minkowitz, Alparslan Turan, Yu-Kun Chiang, Mark A Evashenk, Pamela P Palmer

Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Pain practice : the official journal of World Institute of Pain, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01539538 (A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
10.0field-weighted citation impact, top 2% 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.

NCT01539538 phase3completednot on this map

A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

TypeinterventionalSponsorTalphera, IncRan2012 to 2012Enrolled357ConditionsPost-Operative PainArmsSufentanil NanoTab PCA System/15 mcg, morphine IV PCA
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Article
  8. Sublingual Sufentanil Tablet System (SSTS-ZalvisoJournal of clinical medicine · 2022
    Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Postoperative pain management in obstetrics and gynecologyJournal of the Turkish German Gynecological Association · 2020
    Article
  14. Article
  15. Review
  16. Review
  17. 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
    Article
  18. Review
  19. Article
  20. Article
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 4 institutions in 1 country.

Timothy I MelsonInstitution: Helen Keller Hospital, Sheffield, Alabama, U.S.A.
David L Boyer
Harold S Minkowitz
Alparslan Turan
Yu-Kun Chiang
Mark A Evashenk
Pamela P Palmer
AcelRx Pharmaceuticals (United States) · USCleveland Clinic · USHelen Keller Foundation · USMemorial Hermann Memorial City Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProblems with intravenous patient-controlled analgesia (IV PCA) are well known, including invasive route of delivery and pump programming errors. The primary objective of this study was to evaluate patient satisfaction with a novel sublingual sufentanil PCA system (sufentanil sublingual tablet system 15 mcg with a 20-minute lockout interval; SSTS) to IV PCA morphine sulfate 1 mg with a 6-minute lockout interval (IV PCA MS) for the management of acute postoperative pain.

methodsThis was a randomized, open-label, 48-hour non-inferiority study with optional extension to 72 hours at 26 U.S. sites enrolling patients scheduled for elective major open abdominal or orthopedic (hip or knee replacement) surgery. The primary outcome measure was the proportion of patients who responded "good" or "excellent" (collectively "success") at the 48-hour timepoint on the Patient Global Assessment of method of pain control (PGA48).

resultsA total of 357 patients received study drug and 78.5% vs. 65.6% of patients achieved PGA48 "success" for SSTS vs. IV PCA MS, respectively, demonstrating non-inferiority (P < 0.001 using the one-side Z-test against the non-inferiority margin) as well as statistical superiority for treatment effect (P = 0.007). Patients using SSTS reported more rapid onset of analgesia and patient and nurse ease of care and satisfaction scores were higher than IV PCA MS. Adverse events were similar between the 2 groups; however, SSTS had fewer patients experiencing oxygen desaturations below 95% compared to IV PCA MS (P = 0.028).

conclusionsSufentanil sublingual tablet system is a promising new analgesic technology that may address some of the concerns with IV PCA.

Indexed as

Administration, OralAdultAgedAged, 80 and overAnalgesia, Patient-ControlledAnalgesics, OpioidDrug CombinationsFemaleHumansInfusions, IntravenousMaleMiddle AgedMorphinePain MeasurementPostoperative PainSufentanilAnalgesics, OpioidDrug CombinationsMorphineSufentanilTabletsadverse eventsonset of analgesiaopioidoxygen desaturationpatient-controlled analgesiapostoperative painsublingualsublingual tablet systemsufentanil

Identifiers

PMID25155134
PMCPMC4234007
OpenAlexW1986358125

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.