A Phase 4 interventional study of Hydromorphone and Fentanyl in Hydromorphone, Analgesia and ICU, sponsored by Nanfang Hospital, Southern Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 4, Interventional, and Treatment
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.
1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's enrollment of 530 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.
Browse Agnosia studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，loading dose 0.5-2mg，maintenance dose 0.50mg/h
Drug: Hydromorphone
NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，loading dose 0.5-1mg，maintenance dose 0.08-0.2mg/h
Drug: Butorphanol
NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，loading dose 1-2mg/kg，maintenance dose 0.7-10mg/kg/h
Drug: Fentanyl
Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump)
Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)
Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump)
successful analgesic proportion
Proportion of patients in each group who reached the target analgesia score range
Time frame: From date of using the intervention drugs until the date of leaving from icu, up to 28 days
Score
analgesia score, such as CPOT or NRS
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.
Days without delirium or coma
Number of days in which the patient did not experience delirium or coma
Time frame: From date of using the intervention drugs until the date of discharge or death from any cause, up to 28 days
cost during ICU
Hospitalization expenses during ICU
Time frame: from the date of entering hospital until the date of discharging or death from any cause，up to 60 days
Mechanical ventilation-free days
Duration without mechanical ventilation during the use of analgesics
Time frame: From date of using the intervention drugs until the date of retrachealing intubation,leaving icu or death from any cause, up to 28 days
Length of hospital stay
Duration from hospital admission to hospital discharge or death, measured in days.
Time frame: From hospital admission to hospital discharge or death, assessed up to 60 days.
Mortality rate in hospital
Death from any cause before hospital discharge.
Time frame: From hospital admission to hospital discharge or death, assessed up to 60 days.
ICU mortality
Death from any cause before ICU discharge.
Time frame: From ICU admission to ICU discharge or death, assessed up to 60 days.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University