Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation
1 other identifier
interventional
530
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedStudy Start
First participant enrolled
September 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJanuary 20, 2022
January 1, 2022
1.7 years
June 12, 2020
January 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Score
From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
dose of analgesics
From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
Adverse event
From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days
ICU stay
from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.
Study Arms (3)
hydromorphone
EXPERIMENTALNS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，maintenance dose 0.50mg/h
fentanyl
ACTIVE COMPARATORNS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，maintenance dose 0.08-0.2mg/h
Butorphanol
ACTIVE COMPARATORNS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，maintenance dose 0.7-10mg/kg/h
Interventions
Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump)
Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)
Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump)
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- pregnancy；
- can not get pain score from patients
- allergy to drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southern medical university Nanfang hospital
Guangzhou, 510515, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 17, 2020
Study Start
September 4, 2020
Primary Completion
June 1, 2022
Study Completion
September 1, 2022
Last Updated
January 20, 2022
Record last verified: 2022-01