Clinical trial NCT02198404: Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit
Official title: Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Refractory Pains
End of Life Patients
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* contra-indication to soya
* contra-indication to egg lecithin
* Respiratory insufficiency

Primary outcomes:
measure: Feasability of the care without largely pain
timeFrame: at inclusion (day=0), after the care
Secondary outcomes:
measure: asleep delay
timeFrame: at the inclusion (day=0), delay between sleep-inducing medicine injection and asleep
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
affiliation: Nice University Hospital
name: CIAIS Jean-François, PhD
role: PRINCIPAL_INVESTIGATOR
References: