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

NCT ID: NCT03786887

Last Updated: 2018-12-26

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.

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

Keywords

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mechanical ventilation nalbuphine

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

Sponsors

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Hua-Qing Shu

OTHER

Sponsor Role lead

Responsible Party

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Hua-Qing Shu

Associate chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Critical Care Medicine, Union Hospital, Wuhan

Wuhan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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You Shang

Role: CONTACT

Phone: +8615972127819

Email: [email protected]

Facility Contacts

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You Shang

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22388706 (View on PubMed)

Other Identifiers

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HShu

Identifier Type: -

Identifier Source: org_study_id