NCT02734511: PROPOPAL2

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

Completed Phase 3 Last updated 4 June 2024

What this trial tests

Phase 3 trial testing sedation with propofol in Refractory Pains in 20 participants. Completed in 26 September 2019.

Timeline

19 May 2017

Primary endpoint
26 September 2019

26 September 2019

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	19 May 2017
Primary completion	26 September 2019
Estimated completion	26 September 2019
Sites	1 location across France

Drugs / interventions tested

• sedation with propofol — full drug profile →

Conditions studied

• Refractory Pains — all drugs for Refractory Pains →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

18 and older, any sex, with Refractory Pains. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.