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Completed

NCT Number: NCT02198404

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nice University Hospital

Nice, 06000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Exclusion criteria

  • contra-indication to soya
  • contra-indication to egg lecithin
  • Respiratory insufficiency

Treatment and study plan

sedation with propofol

Drug

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

Primary outcomes

  1. 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"

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PROPOPAL1

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2014
Registry last updated
Nov 18, 2023

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.

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