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

Phase 4

• Conditions: Hydromorphone; Analgesia; ICU
• Interventions: Drug: Hydromorphone; Drug: Fentanyl; Drug: Butorphanol

• Registration Number: NCT04436224
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-17
• Study Start: 2020-09-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20
• Primary Completion: 2022-06
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 530

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydromorphone	Hydromorphone	NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，maintenance dose 0.50mg/h
fentanyl	Fentanyl	NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，maintenance dose 0.08-0.2mg/h
Butorphanol	Butorphanol	NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，maintenance dose 0.7-10mg/kg/h

Primary Outcome Measures

Name	Time	Method
successful analgesic proportion	From date of using the intervention drugs until the date of leaving from icu, up to 28 days	Proportion of patients in each group who reached the target analgesia score range

Secondary Outcome Measures

Name	Time	Method
Adverse event	From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days	Adverse event during the study, including hypotension.et
Score	From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days	analgesia score, such as CPOT or NRS
dose of analgesics	From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days	total dose of analgesics during the study
ICU stay	from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.	duration of stay in ICU

Trial Locations

Locations (1)

Southern medical university Nanfang hospital; 🇨🇳 Guangzhou, China