Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department

• Conditions: Fractures Reduction; Joint Dislocation Reduction

• Registration Number: NCT02200744
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

Brief Summary

The purpose of this study is to determine the incidence of recall in patients managed in emergency department with a procedural sedation protocol using propofol in a population of 250 .

Detailed Description

After procedural sedation for fracture or joint dislocation reduction using propofol, adult patients recall will be assessed with a standardised form. This recall assessment will be realised 2 hours (+/- 15 minutes) after the procedural sedation and the day after.

The primary outcome measure will be the recall incidence 2 hours (+/- 15 minutes) after a procedural sedation. A secondary outcome will be the recall incidence one day after the procedural sedation.

The recall will be defined by a positive answer to the third question of the Sandin form (Lancet. 2000;355(9205):707-11).

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04
• Primary Completion: 2016-10
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Adults patients (> 18 years old) who had a procedural sedation in emergency department using propofol for fracture or joint dislocation reduction
• Patients who received an initial injection of Propofol by slow intravenous injection of 1 mg/kg in 20 seconds
• Inclusion less than 2 hours from the injection of Propofol
• Patients who have signed a consent to participate in the study
• Patients covered by social security.

Exclusion Criteria

• Patients under 18 years old
• Patients who cannot signed the informed consent
• Patients who had procedural sedation using other drugs that propofol
• Participation in another study type biomedical research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recall incidence	At 2 hours (+/- 15 minutes) after procedural sedation with propofol	questionnaire of Brice amended by Sandin

Secondary Outcome Measures

Name	Time	Method
Recall incidence	About 24 hours after procedural sedation with propofol	The patient will be contacted by phone the next day after procedural sedation with propofol. They will answer the questionnaire of Brice amended by Sandin
Patient's satisfaction assessment	At 2 hours (+/- 15 minutes) after procedural sedation with propofol	numerical verbal scale

Trial Locations

Locations (4)

Groupe Hospitalier Est Réunion; 🇫🇷 Saint Benoît, La Réunion, France

Centre Hospitalier Gabriel Martin; 🇫🇷 Saint Paul, La Réunion, France

CHU de la Réunion; 🇫🇷 Saint Denis, La Réunion, France

CHU de La Réunion; 🇫🇷 Saint Pierre, La Réunion, France