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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Paracetamol Route in Palliative Care Patients (PARASCIVPALLIA)

Clinicaltrials.gov identifier NCT03944044

Recruitment Status Not yet recruiting

First Posted May 9, 2019

Last update posted May 29, 2019

Study Description

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.

  • Condition or Disease:Palliative Care
  • Intervention/Treatment: Other: Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: This is a comparative, randomized, open, crossover, bicenter clinical trial with SC and IV paracetamol injections successively given to each patient.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Paracetamol Route in Palliative Care Patients : Intravenous Versus Subcutaneous Route Pharmacokinetics, Study Protocol for a Randomized Equivalence Pilot Trial
  • Estimated Study Start Date: June 2019
  • Estimated Primary Completion Date: September 2019
  • Estimated Study Completion Date: March 2021
Arms and interventions
Arm Intervention/treatment
Other: Intravenous route first
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
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.
Other: Subcutaneous route first
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
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.
Outcome Measures
  • Primary Outcome Measures: 1. paracetamolemia dosage after intravenous route [ Time Frame: At injection time ]
    measurement of paracetamol blood concentration after intravenous route
  • 2. paracetamolemia dosage after intravenous route [ Time Frame: 15 minutes after injection ]
    measurement of paracetamol blood concentration after intravenous route
  • 3. paracetamolemia dosage after intravenous route [ Time Frame: 60 minutes after injection ]
    measurement of paracetamol blood concentration after intravenous route
  • 4. paracetamolemia dosage after intravenous route [ Time Frame: 90 minutes after injection ]
    measurement of paracetamol blood concentration after intravenous route
  • 5. paracetamolemia dosage after intravenous route [ Time Frame: 120 minutes after injection ]
    measurement of paracetamol blood concentration after intravenous route
  • 6. paracetamolemia dosage after intravenous route [ Time Frame: 240 minutes after injection ]
    measurement of paracetamol blood concentration after intravenous route
  • 7. paracetamolemia dosage after intravenous route [ Time Frame: 360 minutes after injection ]
    measurement of paracetamol blood concentration after intravenous route
  • 8. paracetamolemia dosage after intravenous route [ Time Frame: 480 minutes after injection ]
    measurement of paracetamol blood concentration after intravenous route
  • 9. paracetamolemia dosage after subcutaneous route [ Time Frame: at injection time ]
    measurement of paracetamol blood concentration after subcutaneous route
  • 10. paracetamolemia dosage after subcutaneous route [ Time Frame: 15 minutes after injection ]
    measurement of paracetamol blood concentration after subcutaneous route
  • 11. paracetamolemia dosage after subcutaneous route [ Time Frame: 30 minutes after injection ]
    measurement of paracetamol blood concentration after subcutaneous route
  • 12. paracetamolemia dosage after subcutaneous route [ Time Frame: 45 minutes after injection ]
    measurement of paracetamol blood concentration after subcutaneous route
  • 13. paracetamolemia dosage after subcutaneous route [ Time Frame: 60 minutes after injection ]
    measurement of paracetamol blood concentration after subcutaneous route
  • 14. paracetamolemia dosage after subcutaneous route [ Time Frame: 90 minutes after injection ]
    measurement of paracetamol blood concentration after subcutaneous route
  • 15. paracetamolemia dosage after subcutaneous route [ Time Frame: 120 minutes after injection ]
    measurement of paracetamol blood concentration after subcutaneous route
  • 16. paracetamolemia dosage after subcutaneous route [ Time Frame: 240 minutes after injection ]
    measurement of paracetamol blood concentration after subcutaneous route
  • 17. paracetamolemia dosage after subcutaneous route [ Time Frame: 360 minutes after injection ]
    measurement of paracetamol blood concentration after subcutaneous route
  • 18. paracetamolemia dosage after subcutaneous route [ Time Frame: 480 minutes after injection ]
    measurement of paracetamol blood concentration after subcutaneous route
  • Secondary Outcome Measures: 1. pain scale [ Time Frame: at injection time ]
    numeric sale (0-10)
  • 2. pain scale [ Time Frame: 15 minutes after injection time ]
    numeric sale (0-10)
  • 3. pain scale [ Time Frame: 60 minutes after injection time ]
    numeric sale (0-10)
  • 4. pain scale [ Time Frame: 90 minutes after injection time ]
    numeric sale (0-10)
  • 5. pain scale [ Time Frame: 120 minutes after injection time ]
    numeric sale (0-10)
  • 6. pain scale [ Time Frame: 240 minutes after injection time ]
    numeric sale (0-10)
  • 7. pain scale [ Time Frame: 360 minutes after injection time ]
    numeric sale (0-10)
  • 8. pain scale [ Time Frame: 480 minutes after injection time ]
    numeric sale (0-10)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

University Hospital, Caen

More Information
  • Responsible Party: University Hospital, Caen
  • ClinicalTrials.gov Identifier: NCT03944044 History of Changes
  • Other Study ID Numbers: 17-245
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: May 29, 2019
  • Last Verified: December 2018
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Hospital, Caen: Paracetamol
    Acetaminophen
    intravenous administration
    Subcutaneous administration
    Palliative care
    pharmacokinetic