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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service de réanimation - Hôpital Purpan

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: REANURSUF

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: May 19, 2011
Registry last updated: May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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