Evidence map›Paper›PMID 28803087›Full record

Trial reportJournal of pain and symptom management2017

Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea: A Pilot Double-Blind Randomized Controlled Trial.

David Hui, Kelly Kilgore, Susan Frisbee-Hume, Minjeong Park, Diane Liu, Diwakar D Balachandran, Eduardo Bruera

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of pain and symptom management, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03834363 (Morphine or Fentanyl for Refractory Dyspnea in COPD), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT03834363 phase4completednot on this mapstarted 2019, after this paper: background citation

Morphine or Fentanyl for Refractory Dyspnea in COPD

TypeinterventionalSponsorHuib A.M. KerstjensRan2019 to 2024Enrolled59ConditionsCOPDArmsFentanyl, Morphine Retard, Placebo patch, Placebo oral capsule
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Article
  9. Current Management Options for Dyspnea in Cancer Patients.Current treatment options in oncology · 2023
    Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Fentanyl treatment for end-of-life dyspnoea relief in advanced cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Article
  15. Review
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.

David HuiDepartment of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org.
Kelly KilgoreDepartment of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.
Susan Frisbee-HumeDepartment of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.
Minjeong ParkDepartment of Biostatistics, MD Anderson Cancer Center, Houston, Texas, USA.
Diane LiuDepartment of Biostatistics, MD Anderson Cancer Center, Houston, Texas, USA.
Diwakar D BalachandranDepartment of Pulmonary Medicine, MD Anderson Cancer Center, Houston, Texas, USA.
Eduardo BrueraDepartment of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Kathrin Milbury · 1985 to 2026
$290.8M
Adjuvant Lorazepam for Agitated Delirium in the Palliative Care UnitR21CA186000 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUI, DAVID · 2015 to 2016
$399k
NCI NIH HHS P30 CA016672NCI NIH HHS R21 CA186000
6 · The paper itself

Abstract

contextEpisodic dyspnea is one of the most common, debilitating, and difficult-to-treat symptoms.

objectiveWe conducted a pilot study to examine the effect of prophylactic fentanyl buccal tablet (FBT) on exercise-induced dyspnea.

methodsIn this parallel, double-blind randomized placebo-controlled trial, opioid-tolerant patients were asked to complete a six-minute walk test (6MWT) at baseline and then a second 6MWT 30 minutes after a single dose of FBT (equivalent to 20-50% of their total opioid dose) or matching placebo. We compared dyspnea Numeric Rating Scale (NRS, 0-10, primary outcome), walk distance, vital signs, neurocognitive function, and adverse events between the two 6MWTs.

resultsAmong 22 patients enrolled, 20 (91%) completed the study. FBT was associated with a significant within-arm reduction in dyspnea NRS between 0 and six minutes (mean change -2.4, 95% CI -3.5, -1.3) and respiratory rate (mean change -2.6, 95% CI -4.7, -0.4). Placebo was also associated with a nonstatistically significant decrease in dyspnea (mean change -1.1). Between-arm comparison of dyspnea scores in the second 6MWT favored FBT, albeit not statistically significant (estimate -0.25, P = 0.068). Global impression revealed more patients in the FBT group than placebo group reporting their dyspnea was at least "somewhat better" in the second 6MWT (4 of 9 vs. 0 of 11, P = 0.03). The other secondary outcomes did not differ significantly between arms.

conclusionsThis study supports that prophylactic FBT was associated with a reduction of exertional dyspnea and was well tolerated. Our findings support the need for larger trials to confirm the therapeutic potential of rapid-onset opioids.

Indexed as

Administration, BuccalAdultAgedAnalgesics, OpioidComorbidityDouble-Blind MethodDyspneaFatigueFemaleFentanylHumansMaleMiddle AgedNeoplasmsPilot ProjectsTreatment OutcomeAnalgesics, OpioidFentanylControlled clinical trialsdyspneafentanylneoplasmsopioid analgesicsphysical exertion

Identifiers

PMID28803087
PMCPMC5705410

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.