Back to resultsHydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation
Primary Purpose
Hydromorphone, Analgesia, ICU
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hydromorphone
Fentanyl
Butorphanol
Sponsored by
About this trial
This is an interventional treatment trial for Hydromorphone
Eligibility Criteria
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
- ....
Sites / Locations
- Southern medical university Nanfang hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
hydromorphone
fentanyl
Butorphanol
Arm Description
NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，maintenance dose 0.50mg/h
NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，maintenance dose 0.08-0.2mg/h
NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，maintenance dose 0.7-10mg/kg/h
Outcomes
Primary Outcome Measures
successful analgesic proportion
Proportion of patients in each group who reached the target analgesia score range
Secondary Outcome Measures
Score
analgesia score, such as CPOT or NRS
dose of analgesics
total dose of analgesics during the study
Adverse event
Adverse event during the study, including hypotension.et
ICU stay
duration of stay in ICU
Full Information
NCT ID
NCT04436224
First Posted
June 12, 2020
Last Updated
January 19, 2022
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04436224
Brief Title
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation
Official Title
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation: A Dose-exploration and Effectiveness Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydromorphone, Analgesia, ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
530 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hydromorphone
Arm Type
Experimental
Arm Description
NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，maintenance dose 0.50mg/h
Arm Title
fentanyl
Arm Type
Active Comparator
Arm Description
NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，maintenance dose 0.08-0.2mg/h
Arm Title
Butorphanol
Arm Type
Active Comparator
Arm Description
NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，maintenance dose 0.7-10mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump)
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)
Intervention Type
Drug
Intervention Name(s)
Butorphanol
Intervention Description
Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump)
Primary Outcome Measure Information:
Title
successful analgesic proportion
Description
Proportion of patients in each group who reached the target analgesia score range
Time Frame
From date of using the intervention drugs until the date of leaving from icu, up to 28 days
Secondary Outcome Measure Information:
Title
Score
Description
analgesia score, such as CPOT or NRS
Time Frame
From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
Title
dose of analgesics
Description
total dose of analgesics during the study
Time Frame
From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
Title
Adverse event
Description
Adverse event during the study, including hypotension.et
Time Frame
From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days
Title
ICU stay
Description
duration of stay in ICU
Time Frame
from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
....
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongbin Hu, doctor
Phone
+8613922483752
Email
hobewoos@163.com
Facility Information:
Facility Name
Southern medical university Nanfang hospital
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbin Hu, doctor
Phone
+8613922483752
Email
hobewoos@163.com
12. IPD Sharing Statement
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Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation
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