Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients (REANURSUF)
Mechanically ventilated patients experiencing pain are frequent in intensive care units (ICU) however their treatment remains unclear. This prospective pharmacodynamic study relates to the analgesia of procedural pains. The primary objective was to determine the 90% effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically ventilated patients.
Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation, reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were included.
During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new LD until BPS was at 3 or 4.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients.|
- The effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4) [ Time Frame: five days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
From 0 to 0,05 µg/kg to a maximum of 4 µg/kg of sufentanil. 7 minutes before nursing 3 nursing per day during 3 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356732
|Service de réanimation - Hôpital Purpan|
|Principal Investigator:||Olivier Fourcade||University Hospital, Toulouse|