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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hydromorphone, Analgesia, ICU

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: Fentanyl
* Drug: Butorphanol


Participation Criteria
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Eligibility Criteria
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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 ....

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. |