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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03786887

Enrollment

Registered

2018-12-26

Start date

2018-10-24

Completion date

2019-10-31

Last updated

2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

mechanical ventilation, nalbuphine

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.

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.

Interventions

DRUGNalbuphine

dosage of nalbuphine

Study design

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactYou Shang

shang_you@126.com+8615972127819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026