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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786887
• Other study ID #: HShu
• Status: Recruiting
• Phase: Phase 4
• Start date: October 24, 2018
• Est. completion date: October 2019

Study information

• Verified date: November 2018
• Source: Wuhan Union Hospital, China
• Contact: You Shang
• Phone: +8615972127819
• Email: shang_you[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Nalbuphine
dosage of nalbuphine

Locations

Country	Name	City	State
China	Department of Critical Care Medicine, Union Hospital, Wuhan	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Hua-Qing Shu

Country where clinical trial is conducted

China, 

References & Publications (1)

Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Génestal 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. — View Citation

Outcome

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