Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients (REANURSUF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01356732
First received: April 19, 2011
Last updated: June 20, 2013
Last verified: June 2013

April 19, 2011
June 20, 2013
January 2010
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01356732 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients
Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mechanical Ventilation
  • Pain
Drug: Sufentanil
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
Experimental: Sufentanil
Intervention: Drug: Sufentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 48th hour of mechanical ventilation
  • mechanical invasive ventilation
  • 48th hour midazolam sedation
  • Behavioral Pain Scale (BPS) at 3 or 4
  • mechanical ventilation of 5 days duration

Exclusion Criteria:

  • Pregnant or breast-feeding woman
  • Subject whose age is upper to 80 years
  • Impossibility to obtain
  • Impossibility of evaluation of the BPS tetraplegia, curare-link , post anoxic coma encephalic death
  • Indication of deep conscious-sedation, malignant cranial trauma, toxic shock, acute respiratory distress syndrome
  • Extra renal clearance OU people in hemodialysis
  • Severe renal failure (creatinine clearance <15ml/min)
  • Severe hepatic failure
  • State of consciousness with impossibility to use self-assessment scale
  • Body mass index >35 ou <18
  • Sufentanil midazolam paracetamol allergy or contraindication
  • Guardianship or confirmed criminal Subject who give his informed consent
  • Morphinic other than sufentanil (morphine, alfentanil fentanyl, remifentanil, nalbuphine, codeine, buprenorphine)
  • Antalgic other than sufentanil and paracetamol ( tramadol nefopam, ketamine, dextropropoxyphene, non steroidal anti-inflammatory drug )
  • MAO inhibitors
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01356732
09 162 02
No
University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Olivier Fourcade University Hospital, Toulouse
University Hospital, Toulouse
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP