AnalgesiaNCT06848452

Clinical Study on the Efficacy and Safety of Hydromorphone for ICU Analgesia

An observational study of Analgesia and ICU Patients Requiring Invasive Mechanical Ventilation, run by Affiliated Hospital of Nantong University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Analgesia, ICU Patients Requiring Invasive Mechanical Ventilation
What is being tested?: no-intervention
How many people: 300 participants
Where: 1 siteChina
Study dates: Mar 2025to 31 Dec 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: ICU patients undergoing invasive mechanical ventilation requiring analgesia and sedation

Who may be able to join

Age ≥18 years and ≤75 years;
For patients requiring sedation and analgesia in ICU, invasive mechanical ventilation time is expected to be ≥24 hours;
Obtain informed consent from patients or family members.

Who cannot join

Under 18 years of age, or over 75 years of age;
pregnancy or breastfeeding;
Known or suspected allergy to opioids (e.g., fentanyl, remifentanil, hydromorphone), butorphanol, midazolam.
General anesthesia surgery within 48 hours;
Acute bronchial asthma.
Acute intestinal obstruction.

Show all 19Show fewer

General anesthesia surgery within 48 hours;
ECG QT interval: male >450 mm seconds, female >470 ms.
Failure to obtain informed consent or authorization;
Participate in other exploratory clinical trials within 6 months prior to screening;
Severe hemodynamic instability (requires epinephrine greater than 0.5ug/kg/min to maintain MAP>65mmHg, or malignant arrhythmias frequently occur)
Use of monoamine oxidase inhibitors.
Chronic pain requires long-term analgesics (>3 months).
Severe, pre-existing substantial liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis, or acute liver failure;
Patients with acute and chronic renal insufficiency requiring dialysis treatment;
Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc.
Patients with a history of alcohol or drug abuse;
Any condition that prevents the correct assessment of cognitive function, such as speech and sensory disorders or mental disorders (language difficulties or organic mental dysfunction);
any other conditions which the investigator considers inappropriate for registration.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoyu Yuan contact

13390940060

yxy11238@163.com

China1 site

Emergency Department of Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
Xiaoyu Yuan, 13390940060, yxy11238@163.com

Other trials in China

About this study

This study is a prospective, single-center clinical study to evaluate the advantages, extensibility and safety of hydromorphone as an analgesic drug in ICU, and to compare it with remifentanil, a traditional sedative drug. These conclusions can guide us to understand the characteristics of analgesic drugs, carry out appropriate pain management, improve the status of ICU patients, and improve the quality of life of patients.

Read the detailed description

This study will be carried out in the Affiliated Hospital of Nantong University. It is expected that 300 ICU patients who received invasive mechanical ventilation and needed analgesia and sedation will be included. The RASS and CPOT scores of 300 patients after using hydromorphone or remifentanil were collected and stored in the clinical trial sample database to evaluate and record the relevant indicators of the subjects. The relevant medical records in clinical treatment were analyzed and studied. Each subject will be numbered and a separate medical record established.

The purpose of this prospective single-center observational clinical study is to : 1 ) evaluate the advantages, extensibility and safety of hydromorphone as an ICU analgesic ; 2 ) Compared with the traditional sedative drug remifentanil. Including gastrointestinal dysfunction, respiratory depression, sedative use, mechanical ventilation time, ICU hospitalization time, extubation failure rate, etc.

Conditions: Analgesia, ICU Patients Requiring Invasive Mechanical Ventilation
Being tested: no-intervention
Keywords: ICU, hydromorphone, analgesia, remifentanil, sedation, respirator support
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

no-interventionOther
no-intervention

Study groups in NCT06848452
Study group	Role	What they receive
Patients treated with hydromorphone and midazolam		Not described Receives: Other: no-intervention
Patients treated with remifentanil and midazolam		Not described Receives: Other: no-intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

RASS score
Richmond Agitation and Sedation Scale score was used to assess the patient's calm state.The maximum value of the score table is 5 and the minimum value is - 4， indicating that the patient 's sedation level changes from ' coma ' to ' aggressive '.The higher the score, the worse the patient 's sedation depth and sedation quality.
Measured: The RASS score at 5, 10, 30 minutes and 1, 2, 3, 4, 8, 12, 16, 20, 24 hours post- dose and before and after each dose adjustment.
CPOT score
Critical care Pain Observation Tool score is used to evaluate the degree of pain in critically ill patients.The maximum value of the score table is 10, and the minimum value is 0.The higher the score, the more serious the pain of the patient.
Measured: The CPOT score at 5, 10, 30 minutes and 1, 2, 3, 4, 8, 12, 16, 20, 24 hours post- dose and before and after each dose adjustment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 202531 Dec 2027

First posted27 Feb 2025
Study startMar 2025 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for AnalgesiaStudies of the same condition, open and under way.
More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06848452
Sponsor's protocol ID: NTFY-YXY-01
Status last verified: Feb 2025
First submitted: 14 Feb 2025
Last updated: 14 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Researchers hope to study data confidentiality.

Publications

Muellejans B, Lopez A, Cross MH, Bonome C, Morrison L, Kirkham AJ. Remifentanil versus fentanyl for analgesia based sedation to provide patient comfort in the intensive care unit: a randomized, double-blind controlled trial [ISRCTN43755713]. Crit Care. 2004 Feb;8(1):R1-R11. doi: 10.1186/cc2398. Epub 2003 Nov 20.
PubMed 14975049
Telekes A. [The role of hydromorphone in pain killing]. Lege Artis Med. 2008 Oct;18(10):675-9. Hungarian.
PubMed 19227610
Hagen N, Thirlwell MP, Dhaliwal HS, Babul N, Harsanyi Z, Darke AC. Steady-state pharmacokinetics of hydromorphone and hydromorphone-3-glucuronide in cancer patients after immediate and controlled-release hydromorphone. J Clin Pharmacol. 1995 Jan;35(1):37-44. doi: 10.1002/j.1552-4604.1995.tb04743.x.
PubMed 7538514
Inturrisi CE. Clinical pharmacology of opioids for pain. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S3-13. doi: 10.1097/00002508-200207001-00002.
PubMed 12479250
Christrup LL. Morphine metabolites. Acta Anaesthesiol Scand. 1997 Jan;41(1 Pt 2):116-22. doi: 10.1111/j.1399-6576.1997.tb04625.x.
PubMed 9061094
Panzer O, Moitra V, Sladen RN. Pharmacology of sedative-analgesic agents: dexmedetomidine, remifentanil, ketamine, volatile anesthetics, and the role of peripheral mu antagonists. Crit Care Clin. 2009 Jul;25(3):451-69, vii. doi: 10.1016/j.ccc.2009.04.004.
PubMed 19576524
Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379
Lombardi RA, Pereira EM, Amaral S, Medeiros HJS, Alrayashi W. Erector spinae plane block versus intravenous opioid for analgesia in pediatric cardiac surgery: A systematic review and meta-analysis. Paediatr Anaesth. 2025 Jan;35(1):17-24. doi: 10.1111/pan.15027. Epub 2024 Oct 15.
PubMed 39403896
Rahu MA, Grap MJ, Ferguson P, Joseph P, Sherman S, Elswick RK Jr. Validity and sensitivity of 6 pain scales in critically ill, intubated adults. Am J Crit Care. 2015 Nov;24(6):514-23. doi: 10.4037/ajcc2015832.
PubMed 26523009
Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.
PubMed 28877145
Bauerschmidt A, Al-Bermani T, Ali S, Bass B, Dorilio J, Rosenberg J, Al-Mufti F. Modern Sedation and Analgesia Strategies in Neurocritical Care. Curr Neurol Neurosci Rep. 2023 Apr;23(4):149-158. doi: 10.1007/s11910-023-01261-7. Epub 2023 Mar 7.
PubMed 36881257
Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
PubMed 23269131

Interested in taking part?

Xiaoyu Yuan

13390940060

yxy11238@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management

All Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on the Efficacy and Safety of Hydromorphone for ICU Analgesia
ClinicalTrials.gov ID: NCT06848452
Acronym / sponsor ID: NTFY-YXY-01
Conditions: Analgesia, ICU Patients Requiring Invasive Mechanical Ventilation
Keywords: ICU, hydromorphone, analgesia, remifentanil, sedation, respirator support
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: Affiliated Hospital of Nantong UniversityUniversity, hospital or other
Study start: Mar 2025 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 27 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Patients treated with hydromorphone and midazolam	–	Other: no-intervention
Patients treated with remifentanil and midazolam	–	Other: no-intervention

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: ICU patients undergoing invasive mechanical ventilation requiring analgesia and sedation

Key inclusion criteria (3 listed)

Age ≥18 years and ≤75 years;
For patients requiring sedation and analgesia in ICU, invasive mechanical ventilation time is expected to be ≥24 hours;
Obtain informed consent from patients or family members.

Key exclusion criteria (19 listed)

Under 18 years of age, or over 75 years of age;
pregnancy or breastfeeding;
Known or suspected allergy to opioids (e.g., fentanyl, remifentanil, hydromorphone), butorphanol, midazolam.
General anesthesia surgery within 48 hours;
Acute bronchial asthma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
no-interventionno-intervention	Other	Patients treated with hydromorphone and midazolam, Patients treated with remifentanil and midazolam

Primary outcome

RASS score
Time frame: The RASS score at 5, 10, 30 minutes and 1, 2, 3, 4, 8, 12, 16, 20, 24 hours post- dose and before and after each dose adjustment.
Richmond Agitation and Sedation Scale score was used to assess the patient's calm state.The maximum value of the score table is 5 and the minimum value is - 4， indicating that the patient 's sedation level changes from ' coma ' to ' aggressive '.The higher the score, the worse the patient 's sedation depth and sedation quality.
CPOT score
Time frame: The CPOT score at 5, 10, 30 minutes and 1, 2, 3, 4, 8, 12, 16, 20, 24 hours post- dose and before and after each dose adjustment.
Critical care Pain Observation Tool score is used to evaluate the degree of pain in critically ill patients.The maximum value of the score table is 10, and the minimum value is 0.The higher the score, the more serious the pain of the patient.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Background: PubMed 14975049Muellejans B, Lopez A, Cross MH, Bonome C, Morrison L, Kirkham AJ. Remifentanil versus fentanyl for analgesia based sedation to provide patient comfort in the intensive care unit: a randomized, double-blind controlled trial [ISRCTN43755713]. Crit Care. 2004 Feb;8(1):R1-R11. doi: 10.1186/cc2398. Epub 2003 Nov 20.
Background: PubMed 19227610Telekes A. [The role of hydromorphone in pain killing]. Lege Artis Med. 2008 Oct;18(10):675-9. Hungarian.
Background: PubMed 7538514Hagen N, Thirlwell MP, Dhaliwal HS, Babul N, Harsanyi Z, Darke AC. Steady-state pharmacokinetics of hydromorphone and hydromorphone-3-glucuronide in cancer patients after immediate and controlled-release hydromorphone. J Clin Pharmacol. 1995 Jan;35(1):37-44. doi: 10.1002/j.1552-4604.1995.tb04743.x.
Background: PubMed 12479250Inturrisi CE. Clinical pharmacology of opioids for pain. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S3-13. doi: 10.1097/00002508-200207001-00002.
Background: PubMed 9061094Christrup LL. Morphine metabolites. Acta Anaesthesiol Scand. 1997 Jan;41(1 Pt 2):116-22. doi: 10.1111/j.1399-6576.1997.tb04625.x.
Background: PubMed 19576524Panzer O, Moitra V, Sladen RN. Pharmacology of sedative-analgesic agents: dexmedetomidine, remifentanil, ketamine, volatile anesthetics, and the role of peripheral mu antagonists. Crit Care Clin. 2009 Jul;25(3):451-69, vii. doi: 10.1016/j.ccc.2009.04.004.
Background: PubMed 30113379Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
Background: PubMed 39403896Lombardi RA, Pereira EM, Amaral S, Medeiros HJS, Alrayashi W. Erector spinae plane block versus intravenous opioid for analgesia in pediatric cardiac surgery: A systematic review and meta-analysis. Paediatr Anaesth. 2025 Jan;35(1):17-24. doi: 10.1111/pan.15027. Epub 2024 Oct 15.
Background: PubMed 26523009Rahu MA, Grap MJ, Ferguson P, Joseph P, Sherman S, Elswick RK Jr. Validity and sensitivity of 6 pain scales in critically ill, intubated adults. Am J Crit Care. 2015 Nov;24(6):514-23. doi: 10.4037/ajcc2015832.
Background: PubMed 28877145Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.
Background: PubMed 36881257Bauerschmidt A, Al-Bermani T, Ali S, Bass B, Dorilio J, Rosenberg J, Al-Mufti F. Modern Sedation and Analgesia Strategies in Neurocritical Care. Curr Neurol Neurosci Rep. 2023 Apr;23(4):149-158. doi: 10.1007/s11910-023-01261-7. Epub 2023 Mar 7.
Background: PubMed 23269131Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
Individual participant dataSharing planned: No. Researchers hope to study data confidentiality.

Related trials for Analgesia

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Xiaoyu Yuan contact

13390940060

yxy11238@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Analgesia and ICU Patients Requiring Invasive Mechanical Ventilation, run by Affiliated Hospital of Nantong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoyu Yuan (13390940060, yxy11238@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RASS score (time frame: The RASS score at 5, 10, 30 minutes and 1, 2, 3, 4, 8, 12, 16, 20, 24 hours post- dose and before and after each dose adjustment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06848452, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.