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Can a new opioid dosing strategy ease ICU pain without ventilators?

NCT ID NCT04436224

Disease control Sponsor: Nanfang Hospital, Southern Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial compares three painkillers, hydromorphone, fentanyl, and butorphanol, given intravenously to ICU patients who are not on mechanical ventilation. The goal is to find the best dose of hydromorphone that achieves effective pain control while monitoring side effects like low blood pressure and delirium. Researchers will track how many patients reach a target pain score and how long they stay in the ICU.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydromorphone, an opioid painkiller, given intravenously
What this could lead to
If hydromorphone works well, it could become a preferred option for managing pain in ICU patients who are breathing on their own, offering effective relief with fewer side effects.
What could go wrong
This is a single-center trial, and results may not apply to all ICU settings. Opioids carry risks like low blood pressure, drowsiness, and delirium, and hydromorphone may not prove better than the alternatives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

530 people

The number who actually took part.

Started

Sep 2020

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

agnosia pain agnosia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Analgesia Hydromorphone ICU

Contacts and locations

Locations

  • Southern medical university Nanfang hospital

    Guangzhou, 510515, China

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