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

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

doi:10.1186/s13063-019-3969-0

Marine Vernant, Cyril Guillaumé + Show 6 more

Open Access

https://doi.org/10.1186/s13063-019-3969-0

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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.

Highlights

Among palliative care (PC) patients who are administered paracetamol, the subcutaneous (SC) route is often an alternative to the intravenous (IV) route
This study shows good safety of paracetamol using the SC route
The secondary objectives are to compare the efficacy of these two modes of administration with regards to pain management and to explore global and cutaneous tolerance of paracetamol administered by the SC route

Summary

Introduction

Among palliative care (PC) patients who are administered paracetamol, the subcutaneous (SC) route is often an alternative to the intravenous (IV) route. Many French palliative teams are 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. In France, paracetamol (acetaminophen) is currently the first-line non-opioid treatment used in pain management. This treatment is administered by different routes depending on the patient’s circumstances.

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