Refractory PainsPhase 4PROPOPAL1NCT02198404
Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit
A Phase 4 study testing sedation with propofol in people with Refractory Pains and End of Life Patients, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Pains, End of Life Patients
- What is being tested?
- sedation with propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2014to 29 Sep 2015
- Phase
- Phase 4
- 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 hospitalized in palliative care unit
- dying terminally patients
- pains resisting to fentanyl and MEOPA (Melange equimolaire Oxygène protocyde d'Azote) (EMONO = equimolar mixture of oxygene and nitrous oxide)
Who cannot join
- contra-indication to soya
- contra-indication to egg lecithin
- Respiratory insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. No proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however Midazolam is the general recommendation.
The investigators believe that Propofol could be used in this instance
Read the detailed description
In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. No proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however Midazolam is the general recommendation.
The investigators believe that Propofol could be used in this instance. The arguments in favour of Propofol include its pharmaco-kinetic characteristics and the fact that it is currently used in other circumstances. Propofol has an action delay which is more rapid that Midazolam therefore its effect is seen 1 minute after a bolus and 5 minutes after for Midazolam. The effect after a short administration lasts only a few minutes however the effect of Midazolam is more prolonged (sometimes several hours). As with Midazolam, a titrated use in weaker doses, should allow sufficient sedation, in the context which interests us, without marked secondary effects.
It is not unreasonable to think that the short action duration of Propofol could minimise respiratory risks in the hours after the treatment compared to Midazolam. With Propofol, the patient wakes as soon as the painful medical procedure has finished, with Midazolam sedation may be prolonged to several hours leading to a risk respiratory depression or secretion retention.
For these reasons; the investigators would like to verify that the use of Propofol is feasible in the context of refractory pain associated with medical procedures (dressing changes, movement during personal care tasks e.g. washing) in the palliative care unit. This is a preliminary study prior to completion of a more extensive multi-centre research project on the role Propofol could play in this situation.
- Conditions
- Refractory Pains, End of Life Patients
- Being tested
- sedation with propofol
- Medical subject headings
- Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sedation with propofolDrug
induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| sedation with propofol | Experimental | propofol injection: induction with propofol at 20 mg/kg/h. When patient is sleeping, the dosage is deceased to 6 mg/kg/h Receives: Drug: sedation with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability of the care without largely pain
The nurse assess if the care could be done without largely pain for the patient. The answer would be "yes" or "not"
Measured: at inclusion (day=0), after the care
Secondary outcomes (1)
asleep delay
time in minutes between injection of propofol and sleep of patient
Measured: at the inclusion (day=0), delay between sleep-inducing medicine injection and asleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study start20 Jun 2014
- Primary completion29 Sep 2015
- Study completion29 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory PainsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CIAIS Jean-François, PhD, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198404
- Sponsor's protocol ID
- 14-PP-01
- Acronym
- PROPOPAL1
- Status last verified
- Nov 2023
- First submitted
- 14 Mar 2014
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit
- ClinicalTrials.gov ID
- NCT02198404
- Acronym / sponsor ID
- PROPOPAL1 / 14-PP-01
- Conditions
- Refractory Pains, End of Life Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Jun 2014
- Primary completion
- 29 Sep 2015 (actual)
- Study completion
- 29 Sep 2015 (actual)
- First posted
- 23 Jul 2014 (estimated)
- 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.
In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. No proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however Midazolam is the general recommendation.
The investigators believe that Propofol could be used in this instance
Detailed description
In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. No proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however Midazolam is the general recommendation.
The investigators believe that Propofol could be used in this instance. The arguments in favour of Propofol include its pharmaco-kinetic characteristics and the fact that it is currently used in other circumstances. Propofol has an action delay which is more rapid that Midazolam therefore its effect is seen 1 minute after a bolus and 5 minutes after for Midazolam. The effect after a short administration lasts only a few minutes however the effect of Midazolam is more prolonged (sometimes several hours). As with Midazolam, a titrated use in weaker doses, should allow sufficient sedation, in the context which interests us, without marked secondary effects.
It is not unreasonable to think that the short action duration of Propofol could minimise respiratory risks in the hours after the treatment compared to Midazolam. With Propofol, the patient wakes as soon as the painful medical procedure has finished, with Midazolam sedation may be prolonged to several hours leading to a risk respiratory depression or secretion retention.
For these reasons; the investigators would like to verify that the use of Propofol is feasible in the context of refractory pain associated with medical procedures (dressing changes, movement during personal care tasks e.g. washing) in the palliative care unit. This is a preliminary study prior to completion of a more extensive multi-centre research project on the role Propofol could play in this situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sedation with propofol | Experimental | Drug: sedation with propofolpropofol injection: induction with propofol at 20 mg/kg/h. When patient is sleeping, the dosage is deceased to 6 mg/kg/h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients hospitalized in palliative care unit
- dying terminally patients
- pains resisting to fentanyl and MEOPA (Melange equimolaire Oxygène protocyde d'Azote) (EMONO = equimolar mixture of oxygene and nitrous oxide)
Key exclusion criteria (3 listed)
- contra-indication to soya
- contra-indication to egg lecithin
- Respiratory insufficiency
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 |
|---|---|---|
| sedation with propofolinduction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h | Drug | sedation with propofol |
Primary outcome
Feasability of the care without largely pain
Time frame: at inclusion (day=0), after the care
The nurse assess if the care could be done without largely pain for the patient. The answer would be "yes" or "not"
1 secondary outcome
asleep delay
Time frame: at the inclusion (day=0), delay between sleep-inducing medicine injection and asleep
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Related trials for Refractory Pains
RecruitingObservational study
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
Chronic Pain, Intractable Pain
Recruiting
Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
Spinal Cord Injury, Neuropathic Pain
Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
Central Post-Stroke Pain, Stroke
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1/2
Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
Intractable Pain, Palliative Care
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.
CIAIS Jean-François, PhD principal investigator
Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sedation with propofol in people with Refractory Pains and End of Life Patients, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 18 Nov 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability of the care without largely pain (time frame: at inclusion (day=0), after the care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.