Pilot study of the pharmacokinetic profile of paracetamol subcutaneously versus intravenously in patients receiving palliative care
- Conditions
- Major patients in palliative careMedDRA version: 20.0 Level: PT Classification code 10059513 Term: Palliative care System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2018-000080-85-FR
- Lead Sponsor
- CHU CAE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 20
• Patient hospitalized (18 years or older) with a pathology in palliative care (defined by WHO as active, complete care, given to patients whose condition does not respond to curative treatment)
• -Disposant of functional central IV pathway with presence of reflux (implantable venous site, picc-line, central line)
• -Presenting spontaneous pain, not related to the care, with a numerical scale (EN) superior to 3/10 or having a prescription of paracetamol in systematic in its usual treatment.
• Patient able to self-assess pain with an EN
• Absence of contraindication to paracetamol
• -Absence of contraindication to the administration of alternative analgesics (weak opioid, strong opioid, NSAID) during the time of the realization of the protocol and periods of wash out.
• Possibility of absence of paracetamol in the previous 24 hours (absence of fever for example)
• Have a blood test that is less than 7 days old and does not show hepatic or end-stage renal insufficiency that contraindicates paracetamol administration.
• Patient Agreement to Participate in the Study, Collection of Signed Informed Consent
• The need to be affiliated to the social security system
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
-Patient under 18 years
-Patient under legal protection
-Patient participating in another research protocol or having participated in another protocol within less than 30 days
-Patient with contraindications to paracetamol
-Weight less than 50kg
-Patient not in a palliative situation (as defined by the WHO) of his illness
-Patient with a contraindication to the administration of a subcutaneous treatment (infection or edema at the point of puncture)
-Pregnant or lactating woman
-Patient who received a paracetamol administration in the previous 24 hours
-Patient who received a low opioid (immediate-release tramadol) within 2 hours or a strong opioid (morphine or oxycodone immediate-release injection or oral, fentanyl injection or transmucosal) in the hour before the administration of paracetamol. (As part of the monitoring of tolerance)
-Patient with a fever
-Absence of functional venous pathway
-Absence of communication possible
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine the pharmacokinetic profile of Paracetamol subcutaneously in palliative care patients and compare it to the intravenous pharmacokinetic profile in the same patients;Primary end point(s): Measurement of paracetamolemia to determine AUC0-t, AUC0-00, Cmax, Vd and t1 / 2 for each mode of administration for the same patient and achievement of pharmacokinetic curve.;Timepoint(s) of evaluation of this end point: 8 hours;<br> Secondary Objective: • -Effectiveness on pain control<br> • Tolerance of the route of administration: skin monitoring (change in color, appearance of edema, cutaneous necrosis, allergic reaction) and monitoring of the onset of pain at the puncture by a EN<br> • - Overall tolerance<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): -Efficacy on pain control<br> -Treatment route intolerance: skin monitoring (change in color, appearance of edema, skin necrosis, allergic reaction) and monitoring of the appearance of pain at the point of puncture by an EN<br> - Global tolerance<br> ;Timepoint(s) of evaluation of this end point: day 30