Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Mechanical Ventilation Pain	Drug: Sufentanil	Phase 4


Study Type:	Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores

Drug Information available for: Sufentanil citrate

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:

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 ]


Enrollment:	25
Study Start Date:	January 2010
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sufentanil	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

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01356732

Locations


France
Service de réanimation - Hôpital Purpan
Toulouse, France

Sponsors and Collaborators

University Hospital, Toulouse

Investigators


Principal Investigator:	Olivier Fourcade	University Hospital, Toulouse

More Information

No publications provided


Responsible Party:	University Hospital, Toulouse
ClinicalTrials.gov Identifier:	NCT01356732 History of Changes
Other Study ID Numbers:	09 162 02
Study First Received:	April 19, 2011
Last Updated:	June 20, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:


mechanical ventilation Midazolam Ramsay Sufentanil

Additional relevant MeSH terms:


Sufentanil Adjuvants, Anesthesia Analgesics Analgesics, Opioid Anesthetics Anesthetics, General Anesthetics, Intravenous Central Nervous System Agents	Central Nervous System Depressants Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015

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