Palliative CarePARASCIVPALLNCT03944044
Paracetamol Route in Palliative Care Patients (PARASCIVPALLIA)
A study testing Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol in people with Palliative Care, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2019to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU
Caen, 14000
Marine VERNANT, +33231462474, parascivpallia@gmail.com
Cyril Guillaumé, +33231065149, guillaume-cy@chu-caen.fr
About this study
Official title: Paracetamol Route in Palliative Care Patients : Intravenous Versus Subcutaneous Route Pharmacokinetics, Study Protocol for a Randomized Equivalence Pilot Trial
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
- Being tested
- Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol
- Keywords
- Paracetamol, Acetaminophen, Palliative care, Subcutaneous administration, intravenous administration, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
paracetamolemia dosage after intravenous route
measurement of paracetamol blood concentration after intravenous route
Measured: At injection time
paracetamolemia dosage after intravenous route
measurement of paracetamol blood concentration after intravenous route
Measured: 15 minutes after injection
paracetamolemia dosage after intravenous route
measurement of paracetamol blood concentration after intravenous route
Measured: 60 minutes after injection
paracetamolemia dosage after intravenous route
measurement of paracetamol blood concentration after intravenous route
Measured: 90 minutes after injection
paracetamolemia dosage after intravenous route
measurement of paracetamol blood concentration after intravenous route
Measured: 120 minutes after injection
paracetamolemia dosage after intravenous route
measurement of paracetamol blood concentration after intravenous route
Measured: 240 minutes after injection
paracetamolemia dosage after intravenous route
measurement of paracetamol blood concentration after intravenous route
Measured: 360 minutes after injection
paracetamolemia dosage after intravenous route
measurement of paracetamol blood concentration after intravenous route
Measured: 480 minutes after injection
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: at injection time
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: 15 minutes after injection
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: 30 minutes after injection
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: 45 minutes after injection
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: 60 minutes after injection
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: 90 minutes after injection
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: 120 minutes after injection
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: 240 minutes after injection
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: 360 minutes after injection
paracetamolemia dosage after subcutaneous route
measurement of paracetamol blood concentration after subcutaneous route
Measured: 480 minutes after injection
Secondary outcomes (8)
pain scale
numeric sale (0-10)
Measured: at injection time
pain scale
numeric sale (0-10)
Measured: 15 minutes after injection time
pain scale
numeric sale (0-10)
Measured: 60 minutes after injection time
pain scale
numeric sale (0-10)
Measured: 90 minutes after injection time
pain scale
numeric sale (0-10)
Measured: 120 minutes after injection time
pain scale
numeric sale (0-10)
Measured: 240 minutes after injection time
pain scale
numeric sale (0-10)
Measured: 360 minutes after injection time
pain scale
numeric sale (0-10)
Measured: 480 minutes after injection time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start15 Jul 2019
- Primary completion1 May 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944044
- Sponsor's protocol ID
- 17-245
- Acronym
- PARASCIVPALL
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2019
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32019598
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Route in Palliative Care Patients : Intravenous Versus Subcutaneous Route Pharmacokinetics, Study Protocol for a Randomized Equivalence Pilot Trial
- ClinicalTrials.gov ID
- NCT03944044
- Acronym / sponsor ID
- PARASCIVPALL / 17-245
- Conditions
- Palliative Care
- Keywords
- Paracetamol, Acetaminophen, Palliative care, Subcutaneous administration, intravenous administration, pharmacokinetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a comparative, randomized, open, crossover, bicenter clinical trial with SC and IV paracetamol injections successively given to each patient.
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous route first | Other | Other: Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocolThe first route of administration is designated by randomization. In the subcutaneous group, patients received intravenous route in a second time. |
| Intravenous route first | Other | Other: Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocolThe first route of administration is designated by randomization. In the intravenous group, patients received subcutaneous route in a second time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocolCompare 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 | Intravenous route first, Subcutaneous route first |
Primary outcome
paracetamolemia dosage after intravenous route
Time frame: At injection time
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route
Time frame: 15 minutes after injection
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route
Time frame: 60 minutes after injection
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route
Time frame: 90 minutes after injection
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route
Time frame: 120 minutes after injection
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route
Time frame: 240 minutes after injection
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route
Time frame: 360 minutes after injection
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after intravenous route
Time frame: 480 minutes after injection
measurement of paracetamol blood concentration after intravenous route
paracetamolemia dosage after subcutaneous route
Time frame: at injection time
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route
Time frame: 15 minutes after injection
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route
Time frame: 30 minutes after injection
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route
Time frame: 45 minutes after injection
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route
Time frame: 60 minutes after injection
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route
Time frame: 90 minutes after injection
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route
Time frame: 120 minutes after injection
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route
Time frame: 240 minutes after injection
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route
Time frame: 360 minutes after injection
measurement of paracetamol blood concentration after subcutaneous route
paracetamolemia dosage after subcutaneous route
Time frame: 480 minutes after injection
measurement of paracetamol blood concentration after subcutaneous route
8 secondary outcomes
pain scale
Time frame: at injection time
pain scale
Time frame: 15 minutes after injection time
pain scale
Time frame: 60 minutes after injection time
pain scale
Time frame: 90 minutes after injection time
pain scale
Time frame: 120 minutes after injection time
pain scale
Time frame: 240 minutes after injection time
pain scale
Time frame: 360 minutes after injection time
pain scale
Time frame: 480 minutes after injection time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 32019598Vernant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol in people with Palliative Care, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
paracetamolemia dosage after intravenous route (time frame: At injection time). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03944044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.