Clinical Trial: Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit

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 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. 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 proje
Sponsor: Centre Hospitalier Universitaire de Nice

Current 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"


Original Primary Outcome: Same as current

Current Secondary Outcome: asleep delay [ Time Frame: at the inclusion (day=0), delay between sleep-inducing medicine injection and asleep ]

time in minutes between injection of propofol and sleep of patient


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nice

Dates:
Date Received: March 14, 2014
Date Started: June 2014
Date Completion: February 2016
Last Updated: September 29, 2015
Last Verified: September 2015