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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-24

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nalbuphine

Group Type EXPERIMENTAL

Nalbuphine

Intervention Type DRUG

dosage of nalbuphine

Interventions

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Nalbuphine

dosage of nalbuphine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No