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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-20

Study Completion Date

2015-09-29

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Refractory Pains End of Life Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sedation with propofol

propofol injection: induction with propofol at 20 mg/kg/h. When patient is sleeping, the dosage is deceased to 6 mg/kg/h

Group Type EXPERIMENTAL

sedation with propofol

Intervention Type DRUG

induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h

Interventions

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sedation with propofol

induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h

Intervention Type DRUG

Eligibility Criteria

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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)