Evidence map›Paper›PMID 36428272›Full record

ArticleActa anaesthesiologica Scandinavica2023

Minimal important difference in opioid consumption based on adverse event reduction-A study protocol.

Anders Peder Højer Karlsen, Casper Pedersen, Jens Laigaard, Kasper Højgaard Thybo, Kasper Smidt Gasbjerg, Anja Geisler, Troels Haxholdt Lunn, Daniel Hägi-Pedersen, Janus Christian Jakobsen, Ole Mathiesen

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Acta anaesthesiologica Scandinavica, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 30% 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.

NCT02340052 completednot on this map

Pain Map DK: a Prospective Cohort Study of Pain Treatment in 500 Hip Arthroplasty Patients at Different Danish Hospitals

TypeobservationalSponsorZealand University HospitalRan2014 to 2016Enrolled501ConditionsPostoperative PainArmsPain treatment
NCT02571361 phase4completednot on this map

PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial

TypeinterventionalSponsorDaniel Hägi-PedersenRan2015 to 2018Enrolled556ConditionsPain, PostoperativeArmsParacetamol (1g x 4), Ibuprofen (400 mg x 4), Paracetamol (0,5 g x 4), Ibuprofen (200 mg x 4), Placebo (x4)
NCT03506789 phase4completednot on this map

Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty - A Randomized Blinded Placebo-controlled Clinical Trial

TypeinterventionalSponsorNaestved HospitalRan2018 to 2020Enrolled485ConditionsPostoperative PainArmsDexamethasone, Placebos
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

10 authors at 5 institutions in 1 country.

Anders Peder Højer KarlsenDepartment of Anaesthesiology, Centre for Anaesthesiological Research, Zealand University Hospital, Køge, Denmark.ORCID https://orcid.org/0000-0002-0338-3751
Casper PedersenDepartment of Anaesthesiology, Centre for Anaesthesiological Research, Zealand University Hospital, Køge, Denmark.ORCID https://orcid.org/0000-0002-3531-8161
Jens LaigaardDepartment of Orthopaedic Surgery and Traumatology, Bispebjerg Hospital, Copenhagen, Denmark.ORCID https://orcid.org/0000-0001-5297-3769
Kasper Højgaard ThyboDepartment of Anaesthesiology, Centre for Anaesthesiological Research, Zealand University Hospital, Køge, Denmark.ORCID https://orcid.org/0000-0002-4727-3132
Kasper Smidt GasbjergDepartment of Anaesthesiology, Centre for Anaesthesiological Research, Zealand University Hospital, Køge, Denmark.ORCID https://orcid.org/0000-0003-1484-483X
Anja GeislerDepartment of Anaesthesiology, Centre for Anaesthesiological Research, Zealand University Hospital, Køge, Denmark.ORCID https://orcid.org/0000-0002-2461-2672
Troels Haxholdt LunnDepartment of Anaesthesiology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Daniel Hägi-PedersenDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0001-8008-6614
Janus Christian JakobsenDepartment of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
Ole MathiesenDepartment of Anaesthesiology, Centre for Anaesthesiological Research, Zealand University Hospital, Køge, Denmark.ORCID https://orcid.org/0000-0003-4544-0619
University of Copenhagen · DKZealand University Hospital Køge · DKBispebjerg Hospital · DKFrederiksberg Hospital · DKUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe patient-relevant minimal important difference for opioid consumption remains undetermined, despite its frequent use as primary outcome in trials on postoperative pain management. A minimal important difference is necessary to evaluate whether significant trial results are clinically relevant. Further, it can be used as effect size to ensure that trials are powered to find clinically relevant effects. By exploring the dose-response relationship between postoperative opioid consumption and opioid-related adverse effects, we aim to approximate the minimal important difference in opioid consumption anchored to opioid-related adverse effects.

methodsThis is a post-hoc analysis of aggregated data from two clinical trials (PANSAID NCT02571361 and DEX2TKA NCT03506789) and one observational cohort study (Pain Map NCT02340052) on pain management after total hip and knee arthroplasty. The primary outcome is the Hodges-Lehmann median difference in opioid consumption between patients with no opioid-related adverse effects and patients experiencing the mildest degree of one or more opioid-related adverse effects (i.e., mild nausea, sedation and/or dizziness or vomiting). Secondary outcomes include the Hodges-Lehmann median difference in opioid consumption that corresponds to one point on a cumulated opioid-related adverse event 0-10 scale. Further, we will explore the proportion of patients that experience opioid-related adverse effects for consecutive opioid dose intervals of 2 mg iv morphine equivalents. Quantile regression will be used to assess any significant interactions with patient baseline characteristics.

conclusionsThis study will hopefully bring us one step closer to determining relevant opioid reductions and thereby improve our understanding of intervention effects and planning of future trials.

Indexed as

Analgesics, OpioidPostoperative PainClinical Trials, Phase IV as TopicCohort StudiesHumansMorphineMulticenter Studies as TopicObservational Studies as TopicPain ManagementRandomized Controlled Trials as TopicAnalgesics, OpioidMorphinehip arthroplastyknee arthroplastyminimal important differenceopioid consumptionpostoperative pain management

Identifiers

PMID36428272
PMCPMC10107239
OpenAlexW4310231288

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.