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

Pain Clinical Trial

— REANURSUF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356732
• Other study ID #: 09 162 02
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2011
• Last updated: May 10, 2017
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
France	Service de réanimation - Hôpital Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Génestal 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4)		five days