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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04436224
Other study ID # nfyyicu002
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 4, 2020
Est. completion date September 2022

Study information

Verified date January 2022
Source Nanfang Hospital of Southern Medical University
Contact Hongbin Hu, doctor
Phone +8613922483752
Email hobewoos@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 530
Est. completion date September 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Hydromorphone
Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ,IV-Pump)
Fentanyl
Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)
Butorphanol
Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg,IV-Pump)

Locations

Country Name City State
China Southern medical university Nanfang hospital Guangzhou

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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.
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