The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of this study is to determine the effective nalbuphine dose in 90% of intubated patients in the ICU, including the continuous infusion dose and a bolus dose during moving to the lateral decubitus position. Pain will assessed using a Behavioural Pain Scale (BPS) requiring a score of 3-4.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2018
CompletedFirst Submitted
Initial submission to the registry
December 3, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedDecember 26, 2018
November 1, 2018
11 months
December 3, 2018
December 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Continuous pumping dose of nalbuphine
The effective continuous infusion dose of nalbuphine to obtain a satisfactory analgesia
2 days
Nalbuphine bolus dose
The effective dose of a nalbuphine bolus to obtain a satisfactory analgesia
3 days
Study Arms (1)
Nalbuphine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Mechanical invasive ventilation
- Sedated only with nalbuphine
You may not qualify if:
- Pregnant or breast-feeding woman
- Age below 18 or over 80 years
- An indication for deep sedation (e.g.the initial stage of septic shock, acute brain injury or acute respiratory distress syndrome)
- Renal dialysis
- The inability to assess pain by the BPS scale (e.g. paralysis)
- BMI less than 18 or more than 35
- Preadmission use of opioid analgesic for chronic pain
- Severe hepatic failure
- State of consciousness with impossibility to use self-assessment scale; monoamine oxidase inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hua-Qing Shulead
Study Sites (1)
Department of Critical Care Medicine, Union Hospital, Wuhan
Wuhan, China
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: 22388706BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate chief physician
Study Record Dates
First Submitted
December 3, 2018
First Posted
December 26, 2018
Study Start
October 24, 2018
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
December 26, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share