Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02198404 |
| Other study ID # |
14-PP-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2014 |
| Est. completion date |
September 29, 2015 |
Study information
| Verified date |
November 2023 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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
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.
