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The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03786887
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Information provided by (Responsible Party):
Hua-Qing Shu, Wuhan Union Hospital, China

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Nalbuphine Phase 4

Detailed Description:

The continuous nalbuphine infusion dose starts at 100ug/kg/h, if the BPS scores reaches 3-4, the continuous infusion dose would be decreased by 20 ug/kg/h for next patients. If not, increased by 20 ug/kg/h.

The nalbuphine bolus is injected 5 min before turning the patients and the dose (starting at 0) is increased by 0.05 mg/kg, prior to each subsequent turn to lateral decubitus until a BPS score of 3-4 is obtained.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nalbuphine Drug: Nalbuphine
dosage of nalbuphine

Primary Outcome Measures :
  1. Continuous pumping dose of nalbuphine [ Time Frame: 2 days ]
    The effective continuous infusion dose of nalbuphine to obtain a satisfactory analgesia

  2. Nalbuphine bolus dose [ Time Frame: 3 days ]
    The effective dose of a nalbuphine bolus to obtain a satisfactory analgesia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mechanical invasive ventilation
  • Sedated only with nalbuphine

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03786887

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Contact: You Shang +8615972127819

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Department of Critical Care Medicine, Union Hospital, Wuhan Recruiting
Wuhan, China
Contact: You Shang         
Sponsors and Collaborators
Hua-Qing Shu

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Responsible Party: Hua-Qing Shu, Associate chief physician, Wuhan Union Hospital, China Identifier: NCT03786887     History of Changes
Other Study ID Numbers: HShu
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hua-Qing Shu, Wuhan Union Hospital, China:
mechanical ventilation

Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents