Evidence map›Paper›PMID 33863862›Full record

ArticlePain2021

Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations.

Jennifer S Gewandter, Shannon M Smith, Robert H Dworkin, Dennis C Turk, Tong J Gan, Ian Gilron, Sharon Hertz, Nathaniel P Katz, John D Markman, Srinivasa N Raja and 30 more

Open access · greenAbstract read
In one paragraph

Article in Pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
6.3field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Cannabinoids and opioid consumption in cancer pain: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
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  4. Opioid-sparing effect of cannabinoids for analgesia: an updated systematic review and meta-analysis of preclinical and clinical studies.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022
    Pooled it
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  9. Transcutaneous electrical acupoint stimulation for cancer-related pain management in patients receiving chronic opioid therapy: a randomized clinical trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
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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

40 authors at 20 institutions in 4 countries.

Jennifer S GewandterUniversity of Rochester Medical Center, Department of Anesthesiology and Perioperative Medicine; Department of Psychiatry; Department of Neurology; the Center for Health and Technology, Department of Neurosurgery,Rochester, NY, United States.
Shannon M SmithUniversity of Rochester Medical Center, Department of Anesthesiology and Perioperative Medicine; Department of Psychiatry; Department of Neurology; the Center for Health and Technology, Department of Neurosurgery,Rochester, NY, United States.
Robert H DworkinUniversity of Rochester Medical Center, Department of Anesthesiology and Perioperative Medicine; Department of Psychiatry; Department of Neurology; the Center for Health and Technology, Department of Neurosurgery,Rochester, NY, United States.
Dennis C TurkUniversity of Washington, Department of Anesthesiology and Pain Medicine, Seattle, WA, United States.
Tong J GanStony Brook University, Renaissance School of Medicine, Department of Anesthesiology Stony Brook, NY, United States.
Ian GilronQueens University, Kingston, Department of Anesthesiology and Perioperative Medicine, ON, Canada.
Sharon HertzFormally: U.S. Food and Drug Administration, Division of Anesthesiology, Addiction Medicine, and Pain Medicine Silver Spring, MD, United States.
Nathaniel P KatzWCG, Department of Analgesic Solutions, Wayland, MA, United States.
John D MarkmanUniversity of Rochester Medical Center, Department of Anesthesiology and Perioperative Medicine; Department of Psychiatry; Department of Neurology; the Center for Health and Technology, Department of Neurosurgery,Rochester, NY, United States.
Srinivasa N RajaJohns Hopkins School of Medicine, Department of Anesthesiology and Critical care Medicine; Department of Psychiatry and Behavioral Medicine, Baltimore, MD, United States.
Michael C RowbothamUniversity of California San Francisco, Departments of Anesthesia and Neurology San Francisco, CA, United States.
Brett R StaceyUniversity of Washington, Department of Anesthesiology and Pain Medicine, Seattle, WA, United States.
Eric C StrainJohns Hopkins School of Medicine, Department of Anesthesiology and Critical care Medicine; Department of Psychiatry and Behavioral Medicine, Baltimore, MD, United States.
Denham S WardUniversity of Rochester Medical Center, Department of Anesthesiology and Perioperative Medicine; Department of Psychiatry; Department of Neurology; the Center for Health and Technology, Department of Neurosurgery,Rochester, NY, United States.
John T FarrarUniversity of Pennsylvania, Department of Biostatistics, Epidemiology, and Informatics, Philadelphia, PA, United States.
Kurt KroenkeIndiana University School of Medicine, Center for Health Services and Outcomes Research, Indianapolis, IN, United States.
James P RathmellBrigham and Women's Hospital/Harvard Medical School, Department of Anesthesiology and Perioperative Medicine; Deparment of Neurology; Department of Psychiatry, Boston, MA, United States.
Richard RauckCarolinas Pain Institute, Charlotte, NC, United States.
Colville BrownInnocoll, Department of Research and Development and Medical Affairs, Athlone, Ireland.
Penney CowanAmerican Chronic Pain Association, Rocklin, CA, United States.
Robert R EdwardsBrigham and Women's Hospital/Harvard Medical School, Department of Anesthesiology and Perioperative Medicine; Deparment of Neurology; Department of Psychiatry, Boston, MA, United States.
James C EisenachWake Forest School of Medicine, Department of Anesthesiology, Winston-Salem, NC, United States.
McKenzie FergusonSouthern Illinois University Edwardsville, Department of Pharmacy Practice Edwardsville, IL, United States.
Roy FreemanBrigham and Women's Hospital/Harvard Medical School, Department of Anesthesiology and Perioperative Medicine; Deparment of Neurology; Department of Psychiatry, Boston, MA, United States.
Roy GrayGW Pharmaceuticals, Department of Discovery Research, Cambridge, United Kingdom.
Kathryn GiblinBiogen, Cambridge, MA, United States.
Hanna Grol-ProkopczykUniversity at Buffalo, Department of Sociology, Buffalo, NY, United States.
Jennifer HaythornthwaiteJohns Hopkins School of Medicine, Department of Anesthesiology and Critical care Medicine; Department of Psychiatry and Behavioral Medicine, Baltimore, MD, United States.
Robert N JamisonBrigham and Women's Hospital/Harvard Medical School, Department of Anesthesiology and Perioperative Medicine; Deparment of Neurology; Department of Psychiatry, Boston, MA, United States.
Marc MartelMcGill University, Departments of Dentistry and Anesthesiology Montreal, QC, Canada.
Ewan McNicolMCPHS University, Department of Pharmacy Practice, Boston, MA, United States.
Michael L OshinskyNational National Institute of Neurological Disorders and Stroke, Bethesda, MD, United States.
Friedhelm SandbrinkU.S. Department of Veterans Affairs/George Washington University, Washington, DC, United States.
Joachim ScholzBiogen, Cambridge, MA, United States.
Richard ScrantonFormally: Pacira, Division of Research and Development, Parsippany, NY, United States.
Lee S SimonSDG LLC, Cambridge, MA, United States.
Deborah SteinerSarepta, Cambridge, MA, United States.
Kenneth VerburgPfizer, NYC, New York, NY, United States.
Ajay D WasanUniversity of Pittsburgh, Departments of Anesthesiology and Perioperative Medicine and Psychiatry, Pittsburgh, PA, United States.
Kerry WentworthFlexion Therapeutics, Department of Regulatory Affairs, Burlington, MA, United States.
University of Rochester Medical Center · USBiogen (United States) · USBoston University · USJohns Hopkins Medicine · USUniversity of Washington · USAmerican Chronic Pain AssociationBrigham and Women's Hospital · USCarolinas Pain Institute · USClinical Solutions · USGeorge Washington University · USGW Pharmaceuticals (United Kingdom) · GBHarvard University · USIndiana University – Purdue University Indianapolis · USInnocoll (Ireland) · IEJohns Hopkins University · USMcGill University · CAMCPHS University · USNational Institute of Neurological Disorders and Stroke · USPacira (United States) · USPfizer (United States) · US

Funding

Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private PartnershipU01FD005936 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2016 to 2020
$2.5M
FDA HHS U01 FD005936
6 · The paper itself

Abstract

abstractRandomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (eg, opioid use disorder) and adverse outcomes (eg, respiratory depression and falls). The risks and adverse outcomes associated with opioid analgesics have prompted efforts to reduce their use in the treatment of both acute and chronic pain. This article presents Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus recommendations for the design of opioid-sparing clinical trials. The recommendations presented in this article are based on the following definition of an opioid-sparing intervention: any intervention that (1) prevents the initiation of treatment with opioid analgesics, (2) decreases the duration of such treatment, (3) reduces the total dosages of opioids that are prescribed for or used by patients, or (4) reduces opioid-related adverse outcomes (without increasing opioid dosages), all without causing an unacceptable increase in pain. These recommendations are based on the results of a background review, presentations and discussions at an IMMPACT consensus meeting, and iterative drafts of this article modified to accommodate input from the co-authors. We discuss opioid sparing definitions, study objectives, outcome measures, the assessment of opioid-related adverse events, incorporation of adequate pain control in trial design, interpretation of research findings, and future research priorities to inform opioid-sparing trial methods. The considerations and recommendations presented in this article are meant to help guide the design, conduct, analysis, and interpretation of future trials.

Indexed as

Analgesics, OpioidChronic PainHumansPain ManagementPain MeasurementAnalgesics, Opioid

Identifiers

PMID33863862
PMCPMC8497633
OpenAlexW3153007121

What OpenQuestion holds

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Registered trials

None linked

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.