Analgesia Clinical Trial
Official title:
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.
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 - .... |
Country | Name | City | State |
---|---|---|---|
China | Southern medical university Nanfang hospital | Guangzhou |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University |
China,
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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