Evidence map›Paper›PMID 26797808›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2017

External Validation of a Recently Developed Population Pharmacokinetic Model for Hydromorphone During Postoperative Pain Therapy.

Harald Ihmsen, Doris Rohde, Jürgen Schüttler, Christian Jeleazcov

Registry-linked trialAbstract readRandomized Controlled TrialValidation Study
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02035709 (Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT02035709 phase4completednot on this map

Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) After Elective Cardiac Surgery

TypeinterventionalSponsorUniversity of Erlangen-Nürnberg Medical SchoolRan2013 to 2015Enrolled50ConditionsPostoperative PainArmsHydromorphone
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. 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

4 authors.

Harald IhmsenAnästhesiologische Klinik, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Krankenhausstrasse 12, 91054, Erlangen, Germany.
Doris RohdeAnästhesiologische Klinik, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Krankenhausstrasse 12, 91054, Erlangen, Germany.
Jürgen SchüttlerAnästhesiologische Klinik, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Krankenhausstrasse 12, 91054, Erlangen, Germany.
Christian JeleazcovAnästhesiologische Klinik, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Krankenhausstrasse 12, 91054, Erlangen, Germany. christian.jeleazcov@kfa.imed.uni-erlangen.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveWe recently developed a new population pharmacokinetic model for hydromorphone in patients including age and bodyweight as covariates. The aim of the present study was to evaluate prospectively the predictive performance of this new model during postoperative pain therapy.

methodsThis was a prospective, single-blinded, randomized, single-center study with two parallel arms. Fifty patients aged 40-85 years undergoing cardiac surgery involving thoracotomy were enrolled. Hydromorphone was administered postoperatively on the intensive care unit as target controlled infusion (TCI) for patient controlled analgesia (TCI-PCA) using the new pharmacokinetic model, or as conventional patient controlled analgesia (PCA). Arterial blood samples were taken for measurement of the hydromorphone plasma concentration. The predictive performance of the pharmacokinetic model was assessed by the median performance error (MDPE), the median absolute performance error (MDAPE), wobble and divergence. For comparison, the performance indices were also determined for three older models from the literature.

results903 plasma concentrations of 41 patients were analyzed. The mean values (95 % CI) of MDPE, MDAPE, wobble and divergence for the new pharmacokinetic model were 11.2 % (3.9 to 18.7 %), 28.5 % (23.9 to 33.0 %), 21.4 % (18.0 to 24.9 %) and -1.6 %/h (-2.3 to -0.8 %/h). When compared with older models from the literature, performance was better with less overshoot after bolus doses.

conclusionThe new pharmacokinetic model of hydromorphone showed a good precision and a better performance than older models. It is therefore suitable for TCI with hydromorphone during postoperative pain therapy.

trial registrationEudraCT 2013-002875-16, Clinical Trials NCT02035709.

Indexed as

Models, BiologicalAdultAgedAged, 80 and overAnalgesia, Patient-ControlledAnalgesics, OpioidAnesthetics, IntravenousDrug Dosage CalculationsFemaleHumansHydromorphoneInfusions, IntravenousMaleMiddle AgedPostoperative PainSingle-Blind MethodAnalgesics, OpioidAnesthetics, IntravenousHydromorphone

Identifiers

PMID26797808

What OpenQuestion holds

Textmetadata
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.