Paracetamol Route in Palliative Care Patients (PARASCIVPALLIA)

Palliative Care Clinical Trial

— PARASCIVPALL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03944044
• Other study ID #: 17-245
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palliative Care

Intervention

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.

Locations

Country	Name	City	State
France	CHU	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	At injection time
Primary	paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	15 minutes after injection
Primary	paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	60 minutes after injection
Primary	paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	90 minutes after injection
Primary	paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	120 minutes after injection
Primary	paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	240 minutes after injection
Primary	paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	360 minutes after injection
Primary	paracetamolemia dosage after intravenous route	measurement of paracetamol blood concentration after intravenous route	480 minutes after injection
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	at injection time
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	15 minutes after injection
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	30 minutes after injection
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	45 minutes after injection
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	60 minutes after injection
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	90 minutes after injection
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	120 minutes after injection
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	240 minutes after injection
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	360 minutes after injection
Primary	paracetamolemia dosage after subcutaneous route	measurement of paracetamol blood concentration after subcutaneous route	480 minutes after injection
Secondary	pain scale	numeric sale (0-10)	at injection time
Secondary	pain scale	numeric sale (0-10)	15 minutes after injection time
Secondary	pain scale	numeric sale (0-10)	60 minutes after injection time
Secondary	pain scale	numeric sale (0-10)	90 minutes after injection time
Secondary	pain scale	numeric sale (0-10)	120 minutes after injection time
Secondary	pain scale	numeric sale (0-10)	240 minutes after injection time
Secondary	pain scale	numeric sale (0-10)	360 minutes after injection time
Secondary	pain scale	numeric sale (0-10)	480 minutes after injection time