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

Abstract

Background :Among palliative care patients, the subcutaneous route is often an alternative to the intravenous route, yet pharmacological and clinical data are lacking. Many French palliative teams are now empirically using paracetamol by the subcutaneous route, but there are no data to support this practice. Aim :Compare pharmacokinetic parameters between the intravenous and subcutaneous routes for PC patients. Design : A randomized, open, crossover study in two palliative care centres. 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 palliative care 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 pilot study comparing paracetamol intravenous versus subcutaneous route pharmacokinetics.