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

Abstract

Background: Among 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 are lacking. Many French palliative teams are now empirically using paracetamol by the SC route, but there are no data to support this practice.Aim: Compare pharmacokinetic (PK) parameters between the IV and SC routes for PC patients.Design: A randomized, open, crossover study in two PC centers. The primary endpoints are AUC0-t, AUC0-, Cmax, and Vd et t1/2. All adverse events will be reported for a safety analysis.Setting/participants: 20 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 in the usual treatment. They also have to meet all eligibility criteria.Conclusion: First study comparing PK parameters for IV paracetamol versus SC paracetamol.Trial registration:Clinical trial register number NCT03944044, 2019-06-04https://clinicaltrials.gov/ct2/show/NCT03944044Committee for the protection of persons (CPP) 18.09.05.58206 approval 2018/10/4National Drug Safety Agency (ANSM: Agence Nationale de Sécurité Médicament) MEDAECNAT-2018-09-00009 approval 2018/11/29