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

Phase 4

• Conditions: Pain
• Interventions: Drug: Nalbuphine

• Registration Number: NCT03786887
• Lead Sponsor: Hua-Qing Shu

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.

Study Timeline

• Study Start: 2018-10-24
• Status Verified: 2018-11
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-24
• Last Update Submitted: 2018-12-24
• Study First Posted: 2018-12-26
• Last Update Posted: 2018-12-26
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Nalbuphine	Nalbuphine	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Critical Care Medicine, Union Hospital, Wuhan; 🇨🇳 Wuhan, China