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

Toulouse University Hospital

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Drug: Sufentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT01356732

09 162 02

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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
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