Evidence map›Paper›PMID 32019598›Full record

ArticleTrials2020

Intravenous versus subcutaneous route pharmacokinetics of paracetamol (acetaminophen) in palliative care patients: study protocol for a randomized trial (ParaSCIVPallia).

Marine Vernant, Marie Lepoupet, Christian Creveuil, Antoine Alix, Charlotte Gourio, Laure Peyro-Saint-Paul, Veronique Lelong-Boulouard, Cyril Guillaumé

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03944044 (Paracetamol Route in Palliative Care Patients), which is 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
0.3field-weighted citation impact, top 40% 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.

NCT03944044 naunknown statusnot on this map

Paracetamol Route in Palliative Care Patients : Intravenous Versus Subcutaneous Route Pharmacokinetics, Study Protocol for a Randomized Equivalence Pilot Trial

TypeinterventionalSponsorUniversity Hospital, CaenRan2019 to 2024Enrolled20ConditionsPalliative CareArmsParacetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol
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

8 authors at 2 institutions in 1 country.

Marine VernantPain and Palliative Care Department and Regional Palliative Care Unit (RPCU) Maurice Abiven of Fondation de la Miséricorde, Caen University Hospital, CHU de Caen- avenue de la côte de Nacre, 14000, Caen, France. mvernant@fondation-misericorde.fr.ORCID https://orcid.org/0000-0002-9534-8469
Marie LepoupetPain and Palliative Care Department, Caen University Hospital, 14000, Caen, France.
Christian CreveuilClinical Research Department, Caen University Hospital, 14000, Caen, France.
Antoine AlixCaen University Hospital, Pharmacy, 14000, Caen, France.
Charlotte GourioCaen University Hospital, Pharmacy, 14000, Caen, France.
Laure Peyro-Saint-PaulClinical Research Department, Caen University Hospital, 14000, Caen, France.
Veronique Lelong-BoulouardClinical Research Department, Caen University Hospital, 14000, Caen, France.
Cyril GuillauméPain and Palliative Care Department, Caen University Hospital, 14000, Caen, France.
Université de Caen Normandie · FRCentre Hospitalier Universitaire de Caen Normandie · FR

Funding

centre Hospitalier Universitaire de Caen NA
6 · The paper itself

Abstract

backgroundAmong palliative care (PC) patients who are administered paracetamol, the subcutaneous (SC) route is often an alternative to the intravenous (IV) route. Yet pharmacological and clinical data on whether these are equivalent pharmacokinetically are lacking. Many French palliative teams are now empirically using paracetamol by the SC route, but there are no data to support this practice. This trial aims to compare the pharmacokinetic (PK) parameters of paracetomol between the IV and SC routes in PC patients. METHODS/

designThis is a randomized, open, crossover study in two PC centers. The primary endpoints are AUC0-t, AUC0-∞, Cmax, Vd, and t1/2. All adverse events will be reported for a safety analysis. Twenty adult PC patients with an IV device having spontaneous pain not related to care, with a numeric pain rate scale > 3/10, or having a systematic prescription of paracetamol as the usual treatment will be included. All patients also have to meet all eligibility criteria.

conclusionThis is the first study comparing PK parameters for IV paracetamol versus SC paracetamol in PC patients.

trial registrationClinicalTrials.gov, NCT03944044. Registered on 4 June 2019. Committee for the protection of persons (CPP) 18.09.05.58206 approval 4 October 2018. National Drug Safety Agency (ANSM; Agence Nationale de Sécurité Médicament) MEDAECNAT-2018-09-00009 approval 29 November 2018.

Indexed as

Multicenter Studies as TopicRandomized Controlled Trials as TopicAcetaminophenAdolescentAdultAgedAged, 80 and overAnalgesics, Non-NarcoticCross-Over StudiesFemaleFranceHumansInjections, IntravenousInjections, SubcutaneousMaleMiddle AgedAcetaminophenAnalgesics, Non-NarcoticAcetaminophenIntravenous routePalliative careParacetamolPharmacokineticsSubcutaneous route

Identifiers

PMID32019598
PMCPMC6998185
OpenAlexW3008576477

What OpenQuestion holds

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LicenceCC BY
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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.