Paracetamol Route in Palliative Care Patients (PARASCIVPALLIA)

Sponsor

University Hospital, Caen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03944044

Collaborator

(none)

Enrollment

Location

Arms

55.6

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Palliative Care	Other: Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This is a comparative, randomized, open, crossover, bicenter clinical trial with SC and IV paracetamol injections successively given to each patient.This is a comparative, randomized, open, crossover, bicenter clinical trial with SC and IV paracetamol injections successively given to each patient.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2019

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

paracetamolemia dosage after intravenous route [At injection time]
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route [15 minutes after injection]
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route [60 minutes after injection]
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route [90 minutes after injection]
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route [120 minutes after injection]
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route [240 minutes after injection]
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route [360 minutes after injection]
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route [480 minutes after injection]
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after subcutaneous route [at injection time]
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route [15 minutes after injection]
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route [30 minutes after injection]
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route [45 minutes after injection]
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route [60 minutes after injection]
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route [90 minutes after injection]
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route [120 minutes after injection]
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route [240 minutes after injection]
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route [360 minutes after injection]
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route [480 minutes after injection]
measurement of paracetamol blood concentration after subcutaneous route

Secondary Outcome Measures

pain scale [at injection time]
numeric sale (0-10)
pain scale [15 minutes after injection time]
numeric sale (0-10)
pain scale [60 minutes after injection time]
numeric sale (0-10)
pain scale [90 minutes after injection time]
numeric sale (0-10)
pain scale [120 minutes after injection time]
numeric sale (0-10)
pain scale [240 minutes after injection time]
numeric sale (0-10)
pain scale [360 minutes after injection time]
numeric sale (0-10)
pain scale [480 minutes after injection time]
numeric sale (0-10)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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