Paracetamol Route in Palliative Care Patients (PARASCIVPALLIA) (PARASCIVPALL)

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

Background: Among palliative-care patients, subcutaneous route is often an alternative to intravenous route yet pharmacological and clinical data are lacking. Many French palliative crew are now using empirically paracetamol by subcutaneous route also there is no data to support this practice. The aim of the present study is to compare pharmacokinetics parameters between intravenous and subcutaneous route for palliative-care patients.

Methods/design: A randomized, open, crossover, bicenter study in two palliative care centers. The aim is to demonstrate the pharmacokinetic equivalence between the two routes of administration. Data analysis will be performed by Wilcoxn's signed Rank Test with an alpha risk of 5 percent. All adverse events will be reported for a safety analysis.

Discussion: This trial may permit, if a pharmacokinetic equivalence is established, to build randomized controlled trials to then assess the efficacy and tolerability of subcutaneous paracetamol administration.

Study Overview

• Status: Recruiting
• Conditions: Palliative Care
• Intervention / Treatment: Other: Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • CHU
    • Contact: Marine VERNANT; Phone Number: +33231462474; Email: parascivpallia@gmail.com
    • Contact: Cyril Guillaumé; Phone Number: +33231065149; Email: guillaume-cy@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients ≥ 18 years old, hospitalized
• Patients in a palliative care situation
• Patients having an intravenous device with the presence of a venous reflux (be implantable venous site, picc-line, central track)
• Patients having a spontaneous pain, not related to care, with a numeric pain rate scale (NPRS) > 3/10 or have a systematic prescription of paracetamol in the usual treatment
• Patients able to do an auto-evaluation of their pain by NPRS
• No contraindications of paracetamol
• No contraindications of alternative antalgic (low opioids, strong opioids, Non-steroidal anti-inflammatory)
• Possibility to not take paracetamol in the previous 24 hours before inclusion
• Patients with a blood test dating back less than 7 days, with no severe renal or hepatic failure
• Patients related with a French social security regime
• Patients accept to participate in the study, with written consent.

Exclusion Criteria:

• Patients under legal protection
• Patients who participate in another study less than 30 days before
• Patients weighing less than 50 kg
• Patients having a contraindication to subcutaneous route
• Pregnant or breastfeeding woman
• Patients who having a paracetamol administration less than 24 hours before the beginning of the inclusion
• Patients who having a low opioid less than 2 hours before or a strong opioid less than one hour before the beginning of administration of paracetamol
• Patients having a fever
• No possibility of communication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Subcutaneous route first; The first route of administration is designated by randomization. In the subcutaneous group, patients received intravenous route in a second time.	Other: Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol; Compare the pharmacokinetic (PK) of SC and intravenous (IV) routes in the same patient in a palliative care situation, to determine if there is a PK equivalence between these two modes of administration of Paracetamol.
OTHER: Intravenous route first; The first route of administration is designated by randomization. In the intravenous group, patients received subcutaneous route in a second time.	Other: Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol; Compare the pharmacokinetic (PK) of SC and intravenous (IV) routes in the same patient in a palliative care situation, to determine if there is a PK equivalence between these two modes of administration of Paracetamol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	At injection time
paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	15 minutes after injection
paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	60 minutes after injection
paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	90 minutes after injection
paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	120 minutes after injection
paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	240 minutes after injection
paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	360 minutes after injection
paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	480 minutes after injection
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	at injection time
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	15 minutes after injection
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	30 minutes after injection
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	45 minutes after injection
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	60 minutes after injection
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	90 minutes after injection
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	120 minutes after injection
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	240 minutes after injection
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	360 minutes after injection
paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	480 minutes after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain scale	numeric sale (0-10)	at injection time
pain scale	numeric sale (0-10)	15 minutes after injection time
pain scale	numeric sale (0-10)	60 minutes after injection time
pain scale	numeric sale (0-10)	90 minutes after injection time
pain scale	numeric sale (0-10)	120 minutes after injection time
pain scale	numeric sale (0-10)	240 minutes after injection time
pain scale	numeric sale (0-10)	360 minutes after injection time
pain scale	numeric sale (0-10)	480 minutes after injection time

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Publications and helpful links

General Publications

• Vernant M, Lepoupet M, Creveuil C, Alix A, Gourio C, Peyro-Saint-Paul L, Lelong-Boulouard V, Guillaume C. Intravenous versus subcutaneous route pharmacokinetics of paracetamol (acetaminophen) in palliative care patients: study protocol for a randomized trial (ParaSCIVPallia). Trials. 2020 Feb 4;21(1):138. doi: 10.1186/s13063-019-3969-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2019
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (ACTUAL): May 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Palliative care; pharmacokinetic; Acetaminophen; Paracetamol; intravenous administration; Subcutaneous administration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 17-245

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No