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

NCT01356732 | Completed Phase 4

• 1 other identifier: 09 162 02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

mechanical ventilation; Midazolam; Ramsay; Sufentanil

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Sufentanil

EXPERIMENTAL

Drug: Sufentanil

Interventions

Sufentanil DRUG

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

Sufentanil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Service de réanimation - Hôpital Purpan

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 22388706 RESULT

MeSH Terms

Conditions

Pain

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Olivier Fourcade

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: May 19, 2011
• Study Start: January 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)