Nice University Hospital
Nice, 06000, France
NCT Number: NCT02198404
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Nice, 06000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h
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"
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
Centre Hospitalier Universitaire de Nice
Other
Acronym: PROPOPAL1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02734511
Neurologic Manifestations, Pain
Nice, Alpes-Maritimes, France
View Trial DetailsNCT07150728
Behavior, Behavioral Symptoms
Kaohsiung City, Taiwan
View Trial DetailsNCT04494698
Acute Low-back Pain, Agnosia
Landover, Maryland, United States
View Trial DetailsNCT04587674
Neurologic Manifestations, Pain
Caen, France
View Trial Details