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

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 4

Conditions: ICU; Analgesia; Hydromorphone

Treatments: Drug: Butorphanol; Drug: Hydromorphone; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT04436224

nfyyicu002

Details and patient eligibility

About

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.

Enrollment: 530 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• ....

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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530 participants in 3 patient groups

hydromorphone

Experimental group

Description:

NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，maintenance dose 0.50mg/h

Treatment:

Drug: Hydromorphone

fentanyl

Active Comparator group

Description:

NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，maintenance dose 0.08-0.2mg/h

Treatment:

Drug: Fentanyl

Butorphanol

Active Comparator group

Description:

NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，maintenance dose 0.7-10mg/kg/h

Treatment:

Drug: Butorphanol