Evidence map›Paper›PMID 26861166›Full record

ArticleBritish journal of clinical pharmacology2016

Pragmatic pharmacology: population pharmacokinetic analysis of fentanyl using remnant samples from children after cardiac surgery.

Sara L Van Driest, Matthew D Marshall, Brian Hachey, Cole Beck, Kim Crum, Jill Owen, Andrew H Smith, Prince J Kannankeril, Alison Woodworth, Richard M Caprioli and 1 more

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
7.2field-weighted citation impact, top 4% 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

19 citing papers in PubMed, 33 citations in OpenAlex.

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  13. Characterizing Fentanyl Variability Using Population Pharmacokinetics in Pediatric Burn Patients.Journal of burn care & research : official publication of the American Burn Association · 2020
    Observational
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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

11 authors at 1 institution in 1 country.

Sara L Van DriestDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Matthew D MarshallDepartment of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN, USA.
Brian HacheyDepartment of Biochemistry, Vanderbilt University Medical Center, Nashville, TN, USA.
Cole BeckDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Kim CrumDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Jill OwenDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Andrew H SmithDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Prince J KannankerilDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Alison WoodworthDepartment of Pathology, Vanderbilt University Medical Center, Nashville, TN, USA.
Richard M CaprioliDepartment of Biochemistry, Vanderbilt University Medical Center, Nashville, TN, USA.
Leena ChoiDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Vanderbilt University Medical Center · US

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Training (pp 214-245)P41GM103391 · NIGMS · VANDERBILT UNIVERSITY · PI SCHEY, KEVIN L · 2012 to 2020
$17.7M
Spatial Analysis of Molecules in Tissue using MALDI-MSR01GM058008 · NIGMS · VANDERBILT UNIVERSITY · PI CAPRIOLI, RICHARD M · 1998 to 2015
$5.8M
The Vanderbilt Institute for Clinical and Translational Research (VICTR)KL2TR000446 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$2.8M
Population Pharmacokinetic and Pharmacodynamic Models in the Presence of OutliersR21AG034412 · NIA · VANDERBILT UNIVERSITY · PI CHOI, LEENA · 2011 to 2012
$365k
NCATS NIH HHS KL2 TR000446NCATS NIH HHS UL1 TR000445NIA NIH HHS R21 AG034412NIGMS NIH HHS P41 GM103391NIGMS NIH HHS R01 GM058008
6 · The paper itself

Abstract

aimsOne barrier contributing to the lack of pharmacokinetic (PK) data in paediatric populations is the need for serial sampling. Analysis of clinically obtained specimens and data may overcome this barrier. To add evidence for the feasibility of this approach, we sought to determine PK parameters for fentanyl in children after cardiac surgery using specimens and data generated in the course of clinical care, without collecting additional blood samples.

methodsWe measured fentanyl concentrations in plasma from leftover clinically-obtained specimens in 130 paediatric cardiac surgery patients and successfully generated a PK dataset using drug dosing data extracted from electronic medical records. Using a population PK approach, we estimated PK parameters for this population, assessed model goodness-of-fit and internal model validation, and performed subset data analyses. Through simulation studies, we compared predicted fentanyl concentrations using model-driven weight-adjusted per kg vs. fixed per kg fentanyl dosing.

resultsFentanyl clearance for a 6.4 kg child, the median weight in our cohort, is 5.7 l h(-1) (2.2-9.2 l h(-1) ), similar to values found in prior formal PK studies. Model assessment and subset analyses indicated the model adequately fit the data. Of the covariates studied, only weight significantly impacted fentanyl kinetics, but substantial inter-individual variability remained. In simulation studies, model-driven weight-adjusted per kg fentanyl dosing led to more consistent therapeutic fentanyl concentrations than fixed per kg dosing.

conclusionsWe show here that population PK modelling using sparse remnant samples and electronic medical records data provides a powerful tool for assessment of drug kinetics and generation of individualized dosing regimens.

Indexed as

Cardiac Surgical ProceduresChild, PreschoolComputer SimulationFemaleFentanylHumansInfantMaleModels, BiologicalFentanylanalgesiaopportunistic researchpaediatricspopulation pharmacokineticspost-operative painpragmatic research

Identifiers

PMID26861166
PMCPMC4876191
OpenAlexW2280830586

What OpenQuestion holds

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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.