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Completed

NCT Number: NCT04436224

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

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.

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Key information

Conditions

Hydromorphone Agnosia Analgesia ICU Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Southern medical university Nanfang hospital

Guangzhou, 510515, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Hydromorphone

Drug

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

Fentanyl

Drug

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

Butorphanol

Drug

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

Primary outcomes

  1. successful analgesic proportion

    Time frame: From date of using the intervention drugs until the date of leaving from icu, up to 28 days

    Proportion of patients in each group who reached the target analgesia score range

Secondary outcomes

  1. Score

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

    analgesia score, such as CPOT or NRS

  2. dose of analgesics

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

    total dose of analgesics during the study

  3. Adverse event

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

    Adverse event during the study, including hypotension.et

  4. ICU stay

    Time frame: from 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

  5. Days without 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

    Number of days in which the patient did not experience delirium or coma

  6. cost during ICU

    Time frame: from the date of entering hospital until the date of discharging or death from any cause，up to 60 days

    Hospitalization expenses during ICU

  7. Mechanical ventilation-free days

    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

    Duration without mechanical ventilation during the use of analgesics

  8. Length of hospital stay

    Time frame: From hospital admission to hospital discharge or death, assessed up to 60 days.

    Duration from hospital admission to hospital discharge or death, measured in days.

  9. Mortality rate in hospital

    Time frame: From hospital admission to hospital discharge or death, assessed up to 60 days.

    Death from any cause before hospital discharge.

  10. ICU mortality

    Time frame: From ICU admission to ICU discharge or death, assessed up to 60 days.

    Death from any cause before ICU discharge.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2020
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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