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Efficiency and Safety of a Procedural Sedation by Propofol on Terminally Ill Patients With Refractory Pain

NCT02734511 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-06-04

No results posted yet for this study

Summary

Relieving symptoms of patients hospitalized in a palliative care unit is a priority. Although they receive appropriate care, they may still experience pain refractory to analgesia or/and to conservative treatment during care procedures. For instance, pain can be caused by the bandaging of carcinological or ischemic wounds, or by the mobilization of traumatic injuries which cannot be specifically treated.

Although these types of situations are rare, they remain unacceptable, especially at the end of life.

According to current recommendations, a short-term sedation treatment can be administered although detailed procedures for this type of sedation have not been very much documented. In reality, midalozam is often used in those cases but it has drawbacks, which is why the investigators have looked into alternatives.

Propofol, which is already widely used in anesthesia and emergency medicine to manage painful procedures, seems to be an interesting molecule because of its pharmacological properties. It allows to quickly reach deep sedation and thus obtain a certain level of comfort for the patient, but also ensures a prompt awakening as soon as care procedures are over, which limits respiratory side effects.

The results from a preliminary study encouraged us to go further and to present a prospective study conducted in multiple centers in order to evaluate the efficiency and safety of a procedural sedation administered by trained doctors who are not anesthesiologists on terminally ill patients with refractory pain hospitalized in a palliative care unit.

Conditions

  • Refractory Pains

Interventions

DRUG

sedation with propofol

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Flora TREMELLAT, MD · Unité de Soins Palliatifs, CHU de Nice

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-19
Primary Completion
2019-09-26
Completion
2019-09-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734511 on ClinicalTrials.gov