Evidence map›Paper›PMID 29140927›Full record

ReviewPain2018

Clinical trial designs and models for analgesic medications for acute pain in neonates, infants, toddlers, children, and adolescents: ACTTION recommendations.

Gary A Walco, Ernest A Kopecky, Steven J Weisman, Jennifer Stinson, Bonnie Stevens, Paul J Desjardins, Charles B Berde, Elliot J Krane, Kanwaljeet J S Anand, Myron Yaster and 8 more

Open access · greenAbstract readReview
In one paragraph

Review in Pain, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
4.5field-weighted citation impact, top 6% 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

13 citing papers in PubMed, 26 citations in OpenAlex.

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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

18 authors at 14 institutions in 2 countries.

Gary A WalcoDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
Ernest A KopeckyCollegium Pharmaceutical, Inc., Canton, MA, USA.
Steven J WeismanDepartments of Anesthesiology and Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI, USA.
Jennifer StinsonDepartment of Nursing Research, Hospital for Sick Children, Toronto, ON, Canada.
Bonnie StevensDepartment of Nursing Research, Hospital for Sick Children, Toronto, ON, Canada.
Paul J DesjardinsPfizer Consumer Healthcare, New York, NY, USA.
Charles B BerdeDepartment of Anesthesiology, Perioperative and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.
Elliot J KraneDepartment of Anesthesia, Stanford University School of Medicine, Stanford, CA, USA.
Kanwaljeet J S AnandDepartment of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
Myron YasterDepartment of Anesthesiology and Critical Care Medicine, Johns Hopkins University Hospital, Baltimore, MD, USA.
Carlton D DampierDepartment of Pediatrics, Emory University, Atlanta, GA, USA.
Robert H DworkinDepartments of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, University of Rochester, Rochester, NY, USA.
Ian GilronDepartments of Anesthesiology and Biomedical Sciences, Queen's University, Kingston, ON, Canada.
Anne M LynnDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
Lynne G MaxwellDepartment of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Srinivasa RajaDepartment of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
Bernard SchachtelYale School of Public Health, New Haven, CT, USA.
Dennis C TurkDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
Hospital for Sick Children · CASeattle Children's Hospital · USStanford University · USBoston Children's Hospital · USChildren's Hospital of Philadelphia · USChildren's Hospital of Wisconsin · USEmory University · USJohns Hopkins Hospital · USJohns Hopkins University · USPfizer (United States) · USQueen's University · CAUniversity of Rochester · USUniversity of Washington · USYale University · 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

Clinical trials to test the safety and efficacy of analgesics across all pediatric age cohorts are needed to avoid inappropriate extrapolation of adult data to children. However, the selection of acute pain models and trial design attributes to maximize assay sensitivity, by pediatric age cohort, remains problematic. Acute pain models used for drug treatment trials in adults are not directly applicable to the pediatric age cohorts-neonates, infants, toddlers, children, and adolescents. Developmental maturation of metabolic enzymes in infants and children must be taken into consideration when designing trials to test analgesic treatments for acute pain. Assessment tools based on the levels of cognitive maturation and behavioral repertoire must be selected as outcome measures. Models and designs of clinical trials of analgesic medications used in the treatment of acute pain in neonates, infants, toddlers, children, and adolescents were reviewed and discussed at an Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Pediatric Pain Research Consortium consensus meeting. Based on extensive reviews and continuing discussions, the authors recommend a number of acute pain clinical trial models and design attributes that have the potential to improve the study of analgesic medications in pediatric populations. Recommendations are also provided regarding additional research needed to support the use of other acute pain models across pediatric age cohorts.

Indexed as

AgingClinical Trials as TopicAcute PainAdolescentAnalgesicsChildChild, PreschoolHumansInfantAnalgesics

Identifiers

PMID29140927
PMCPMC5949239
OpenAlexW2769702202

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.