Clinical Study on the Efficacy and Safety of Hydromorphone for ICU Analgesia
NCT ID: NCT06848452
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2025-03-31
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients treated with hydromorphone and midazolam
no-intervention
no-intervention
Patients treated with remifentanil and midazolam
no-intervention
no-intervention
Interventions
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no-intervention
no-intervention
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Affiliated Hospital of Nantong University
OTHER
Responsible Party
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Locations
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Emergency Department of Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Telekes A. [The role of hydromorphone in pain killing]. Lege Artis Med. 2008 Oct;18(10):675-9. Hungarian.
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.
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.
Christrup LL. Morphine metabolites. Acta Anaesthesiol Scand. 1997 Jan;41(1 Pt 2):116-22. doi: 10.1111/j.1399-6576.1997.tb04625.x.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NTFY-YXY-01
Identifier Type: -
Identifier Source: org_study_id
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