Authorised Phase II and Phase III (Integrated) Adult patients (> 18 years of age) undergoing palliative care (defined by the WHO as active, comprehensive care given to patients whose condition does not respond to curative treatment) of their disease, able to communicate, and with a functional central venous line with reflux, presenting spontaneous pain with a numerical scale greater than 3 or paracetamol as part of their usual treatment.

Pilot study of the pharmacokinetic profile of subcutaneous versus intravenous paracetamol in palliative patients

EU CTIS ID: 2024-518795-31-00

What this study is testing

Determine the pharmacokinetic profile of subcutaneous Paracetamol in palliative care patients and compare it to the intravenous pharmacokinetic profile in the same patients

  • Phase II and Phase III (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - 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).
  • - The need to be affiliated to the social security system
  • - With a functional central IV line with reflux (implantable venous site, picc-line, central line)
  • - 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
  • - Patient able to self-assess pain with an EN
  • - No contraindication to paracetamol

You likely can't join if

  • - Patient under 18 years of age
  • - 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).
  • - Patient with fever
  • - No functional venous line
  • - No communication possible
  • - Patient under legal protection
See the full eligibility criteria
Who can join
  • - 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).
  • - The need to be affiliated to the social security system
  • - With a functional central IV line with reflux (implantable venous site, picc-line, central line)
  • - 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
  • - Patient able to self-assess pain with an EN
  • - No contraindication to paracetamol
  • - No contraindication to the administration of alternative analgesics (weak opioids, strong opioids, NSAIDs) during the protocol and washout periods.
  • - No medical contraindication to the suspension of Paracetamol in the 24 hours preceding the first study administration (e.g. absence of fever).
  • - Have a blood test less than 7 days old, showing no end-stage liver or kidney disease contraindicating paracetamol administration
  • - Patient agreement to take part in study, informed consent signature collected
What rules you out
  • - Patient under 18 years of age
  • - 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).
  • - Patient with fever
  • - No functional venous line
  • - No communication possible
  • - Patient under legal protection
  • - Patient participating in another research protocol or having participated in another protocol within less than 30 days
  • - Patients with contraindications to paracetamol
  • - Weights under 50 kg
  • - Patient is not palliative (as defined by the WHO) for his disease
  • - Patients with contraindications to subcutaneous treatment (infection or edema at puncture site)
  • - Pregnant or breast-feeding women
  • - Patient having received paracetamol within 24 hours prior to the first paracetamol administration in the study

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.