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

December 24, 2018 updated by: Hua-Qing Shu
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Wuhan, China
        • Recruiting
        • Department of Critical Care Medicine, Union Hospital, Wuhan
        • Contact:
          • You Shang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nalbuphine
Drug: Nalbuphine
dosage of nalbuphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous pumping dose of nalbuphine
Time Frame: 2 days
The effective continuous infusion dose of nalbuphine to obtain a satisfactory analgesia
2 days
Nalbuphine bolus dose
Time Frame: 3 days
The effective dose of a nalbuphine bolus to obtain a satisfactory analgesia
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua-Qing Shu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

December 24, 2018

First Posted (Actual)

December 26, 2018

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 24, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HShu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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