Clinical trial NCT01356732: Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients
Official title: Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: mechanical ventilation
Midazolam
Ramsay
Sufentanil
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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
* 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

Primary outcomes:
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)
timeFrame: five days
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service de réanimation - Hôpital Purpan
Study officials:
affiliation: University Hospital, Toulouse
name: Olivier Fourcade
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Genestal M, Minville V, Fourcade O. The 90% effective dose of a sufentanil bolus for the management of painful positioning in intubated patients in the ICU. Eur J Anaesthesiol. 2012 Jun;29(6):280-5. doi: 10.1097/EJA.0b013e328352234d.