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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04436224
Enrollment
530
Registered
2020-06-17
Start date
2020-09-04
Completion date
2022-09-30
Last updated
2022-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydromorphone, Analgesia, ICU

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.

Interventions

DRUGHydromorphone

Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ,IV-Pump)

DRUGFentanyl

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)

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 * ....

Design outcomes

Primary

MeasureTime frameDescription
successful analgesic proportionFrom date of using the intervention drugs until the date of leaving from icu, up to 28 daysProportion of patients in each group who reached the target analgesia score range

Secondary

MeasureTime frameDescription
ScoreFrom date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 daysanalgesia score, such as CPOT or NRS
dose of analgesicsFrom date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 daystotal dose of analgesics during the study
Adverse eventFrom date of using the intervention drugs until the date of discharge or death from any cause, up to 60 daysAdverse event during the study, including hypotension.et
ICU stayfrom 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

Countries

China

Contacts

Primary ContactHongbin Hu, doctor
hobewoos@163.com+8613922483752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026