Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation

Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation: A Dose-exploration and Effectiveness Study

Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the continuous pumping-dose of hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU non-mechanical ventilation patients.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; ICU; Hydromorphone
• Intervention / Treatment: Drug: Hydromorphone; Drug: Fentanyl; Drug: Butorphanol

• Study Type: Interventional
• Enrollment (Anticipated): 530
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hongbin Hu, doctor; Phone Number: +8613922483752; Email: hobewoos@163.com

Study Locations

• China
  • Guangzhou, China, 510515
    • Recruiting
    • Southern Medical University Nanfang Hospital
    • Contact: Hongbin Hu, doctor; Phone Number: +8613922483752; Email: hobewoos@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥18 years old;
• Non-mechanical ventilation patients with expected ICU stay time >24h
• People with moderate to severe pain who need immediate analgesic treatment (NRS ≥ 4 or BPS ≥ 5 points, CPOT ≥ 3);

Exclusion Criteria:

• pregnancy；
• can not get pain score from patients
• allergy to drugs
• ....

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hydromorphone; NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，maintenance dose 0.50mg/h	Drug: Hydromorphone; Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump)
Active Comparator: fentanyl; NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，maintenance dose 0.08-0.2mg/h	Drug: Fentanyl; Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)
Active Comparator: Butorphanol; NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，maintenance dose 0.7-10mg/kg/h	Drug: Butorphanol; Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful analgesic proportion	Proportion of patients in each group who reached the target analgesia score range	From date of using the intervention drugs until the date of leaving from icu, up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score	analgesia score, such as CPOT or NRS	From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
dose of analgesics	total dose of analgesics during the study	From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
Adverse event	Adverse event during the study, including hypotension.et	From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days
ICU stay	duration of stay in ICU	from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Narcotic Antagonists; Respiratory System Agents; Antitussive Agents; Fentanyl; Hydromorphone; Butorphanol
• Other Study ID Numbers: nfyyicu002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No