Paracetamol for Palliative care

Inclusion criteria

• {"criterion_text":"- Hospitalized patient (18 years or older) with a pathology under palliative care (defined by the WHO as active, comprehensive care given to patients whose condition does not respond to curative treatment)- Hospitalized patient (18 years or older) with a pathology under palliative care (defined by the WHO as active, comprehensive care given to patients whose condition does not respond to curative treatment)."}
• {"criterion_text":"- The need to be affiliated to the social security system"}
• {"criterion_text":"- With a functional central IV line with reflux (implantable venous site, picc-line, central line)"}
• {"criterion_text":"- Presenting spontaneous pain, not related to care, with a numerical scale (EN) greater than 3/10 or having a prescription for paracetamol as part of their usual treatment"}
• {"criterion_text":"- Patient able to self-assess pain with an EN"}
• {"criterion_text":"- No contraindication to paracetamol"}
• {"criterion_text":"- No contraindication to the administration of alternative analgesics (weak opioids, strong opioids, NSAIDs) during the protocol and washout periods."}
• {"criterion_text":"- No medical contraindication to the suspension of Paracetamol in the 24 hours preceding the first study administration (e.g. absence of fever)."}
• {"criterion_text":"- Have a blood test less than 7 days old, showing no end-stage liver or kidney disease contraindicating paracetamol administration"}
• {"criterion_text":"- Patient agreement to take part in study, informed consent signature collected"}

Exclusion criteria

• {"criterion_text":"- Patient under 18 years of age"}
• {"criterion_text":"- Patient having received a Weak opioid (immediate-release tramadol) within 2 hours or a Strong opioid (immediate-release morphine or oxycodone, injectable or oral, injectable or transmucosal fentanyl) within one hour prior to administration of paracetamol (as part of tolerance monitoring)."}
• {"criterion_text":"- Patient with fever"}
• {"criterion_text":"- No functional venous line"}
• {"criterion_text":"- No communication possible"}
• {"criterion_text":"- Patient under legal protection"}
• {"criterion_text":"- Patient participating in another research protocol or having participated in another protocol within less than 30 days"}
• {"criterion_text":"- Patients with contraindications to paracetamol"}
• {"criterion_text":"- Weights under 50 kg"}
• {"criterion_text":"- Patient is not palliative (as defined by the WHO) for his disease"}
• {"criterion_text":"- Patients with contraindications to subcutaneous treatment (infection or edema at puncture site)"}
• {"criterion_text":"- Pregnant or breast-feeding women"}
• {"criterion_text":"- Patient having received paracetamol within 24 hours prior to the first paracetamol administration in the study"}

Primary endpoints

• {"endpoint_text":"- Measurement of paracetamolemia to determine AUC0-t, AUC0-, Cmax , Vd and t1/2 for each mode of administration for the same patient, and generation of pharmacokinetic curves.","definition_or_measurement_approach":"Measurement of paracetamolemia to determine AUC0-t, AUC0-∞, Cmax, Vd and t1/2 for each administration route for the same patient; generation of pharmacokinetic curves."}

Secondary endpoints

• {"endpoint_text":"- Pain assessment using a digital scale","definition_or_measurement_approach":"Pain assessed using a digital numeric scale (EN)."}
• {"endpoint_text":"- Skin monitoring and tolerance assessment throughout administration and protocol completion (D0 to D30)","definition_or_measurement_approach":"Skin monitoring for changes (color, edema, necrosis, allergic reaction) and assessment of pain at puncture site from Day 0 to Day 30."}
• {"endpoint_text":"- Safety criterion: systematic collection of adverse events of any grade (CTCAE scale) from the signing of consent to D30 (minimum follow-up period for drug research).","definition_or_measurement_approach":"Systematic collection of adverse events of any grade using CTCAE from consent signing through Day 30."}

France

Earliest CTIS Part Ii Submission Date

15-10-2024

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

433

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Caen Normandie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France