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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436224
• Other study ID #: nfyyicu002
• Status: Recruiting
• Phase: Phase 4
• 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
• 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
• ....

Related Conditions & MeSH terms

• Analgesia
• Hydromorphone
• ICU

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.