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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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02198404
Study type Interventional
Source Centre Hospitalier Universitaire de Nice
Contact
Status Completed
Phase Phase 4
Start date June 20, 2014
Completion date September 29, 2015

See also
  Status Clinical Trial Phase
Completed NCT02734511 - Efficiency and Safety of a Procedural Sedation by Propofol on Terminally Ill Patients With Refractory Pain Phase 3