Paracetamol Route in Palliative Care Patients (PARASCIVPALLIA)

NCT03944044 | Unknown

• 1 other identifier: 17-245
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care

Keywords

Paracetamol; Acetaminophen; Palliative care; Subcutaneous administration; intravenous administration; pharmacokinetic

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (8)

• pain scale

  at injection time

• pain scale

  15 minutes after injection time

• pain scale

  60 minutes after injection time

• pain scale

  90 minutes after injection time

• pain scale

  120 minutes after injection time

Study Arms (2)

Subcutaneous route first

OTHER

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

Intravenous route first

OTHER

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

Interventions

Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol OTHER

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.

Intravenous route first; Subcutaneous route first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU

Caen, 14000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 32019598 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: May 9, 2019
• Study Start: July 15, 2019
• Primary Completion: May 1, 2023
• Study Completion: March 1, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

FR (1)