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

NCT04436224 | Completed Phase 4

• 1 other identifier: NFEC-2020-173
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydromorphone; Analgesia; ICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Score

  From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days

• dose of analgesics

  From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days

• Adverse event

  From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days

• ICU stay

  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

  From date of using the intervention drugs until the date of discharge or death from any cause, up to 28 days

Study Arms (3)

hydromorphone

EXPERIMENTAL

NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，loading dose 0.5-2mg，maintenance dose 0.50mg/h

Drug: Hydromorphone

Butorphanol

ACTIVE COMPARATOR

NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，loading dose 0.5-1mg，maintenance dose 0.08-0.2mg/h

Drug: Butorphanol

fentanyl

ACTIVE COMPARATOR

NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，loading dose 1-2mg/kg，maintenance dose 0.7-10mg/kg/h

Drug: Fentanyl

Interventions

Hydromorphone DRUG

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

hydromorphone

Fentanyl DRUG

Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)

fentanyl

Butorphanol DRUG

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

Butorphanol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• During pregnancy or breastfeeding；
• Confirmed acute severe intracranial or spinal nerve disease caused by vascular, infection, intracranial dilation or injury;
• Non-compensatory acute circulatory failure (severe hypotension with MAP\<55 mmHg even if sufficient fluid resuscitation and vascular compression therapy);
• Severe bradycardia (heart rate\<55 beats/min) or heart block of degree II-III (excluding those with pacemakers installed);
• Unable to obtain pain scores or any other conditions that may seriously interfere with the collection of research data;
• Have used analgesics other than remifentanil during mechanical ventilation in the ICU;
• Having a history of long-term use of opioid drugs or opioid addiction;
• Known allergy history of experimental drugs;
• Suffering from severe or acute asthma, or respiratory depression caused by severe carbon dioxide retention, head injury, and intracranial damage;
• Danger period intestinal obstruction (present or at risk of progression to gastrointestinal obstruction, especially in patients with paralytic intestinal obstruction);
• Having participated in this study or any other intervention studies (any study that assigns patients to different treatment groups);
• Unsuitable to participate in this experiment according to the judgment of the researchers.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Southern medical university Nanfang hospital

Guangzhou, 510515, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

Hydromorphone; Fentanyl; Butorphanol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 17, 2020
• Study Start: September 4, 2020
• Primary Completion: March 29, 2025
• Study Completion: May 30, 2025
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

CN (1)