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

NCT06848452 | Not Yet Recruiting

• 1 other identifier: NTFY-YXY-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia; ICU Patients Requiring Invasive Mechanical Ventilation

Keywords

ICU; hydromorphone; analgesia; remifentanil; sedation; respirator support

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Study Arms (2)

Patients treated with hydromorphone and midazolam

Other: no-intervention

Patients treated with remifentanil and midazolam

Other: no-intervention

Interventions

no-intervention OTHER

no-intervention

Patients treated with hydromorphone and midazolam; Patients treated with remifentanil and midazolam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients undergoing invasive mechanical ventilation requiring analgesia and sedation

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Emergency Department of Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

Related Publications (12)

• 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.

  PMID: 14975049 BACKGROUND

• Telekes A. [The role of hydromorphone in pain killing]. Lege Artis Med. 2008 Oct;18(10):675-9. Hungarian.

  PMID: 19227610 BACKGROUND

• 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.

  PMID: 7538514 BACKGROUND

• 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.

  PMID: 12479250 BACKGROUND

• Christrup LL. Morphine metabolites. Acta Anaesthesiol Scand. 1997 Jan;41(1 Pt 2):116-22. doi: 10.1111/j.1399-6576.1997.tb04625.x.

  PMID: 9061094 BACKGROUND

• 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.

  PMID: 19576524 BACKGROUND

• 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.

  PMID: 30113379 BACKGROUND

• 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.

  PMID: 39403896 BACKGROUND

• 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.

  PMID: 26523009 BACKGROUND

• 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.

  PMID: 28877145 BACKGROUND

• 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.

  PMID: 36881257 BACKGROUND

• 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.

  PMID: 23269131 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaoyu Yuan

CONTACT

13390940060; yxy11238@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 27, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)