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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COMPLETED
55 participants
OBSERVATIONAL
2018-01-01
2018-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mechanically ventilated critically ill patients
Mechanically ventilated critically ill patients who receive opioid as continuous infusion for more than 24 hours
Opioids
Mechanically ventilated critically ill patients who receive continuous opioid infusion for more than 24 hours will be observed for withdrawal symptoms when rate of opioid infusion is disrupted or decreased
Interventions
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Opioids
Mechanically ventilated critically ill patients who receive continuous opioid infusion for more than 24 hours will be observed for withdrawal symptoms when rate of opioid infusion is disrupted or decreased
Eligibility Criteria
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Inclusion Criteria
* On mechanical ventilator at least 24 hours
* Received continuous infusion of opioid at least 24 hours
* Patient or legal surrogate who is willing and able to provide written informed consent and comply with all protocol requirements
Exclusion Criteria
* Preexisting psychiatric diagnosis
* Substance abuse prior to ICU admission
* Chronic alcohol drinking
* Pregnancy
* End-of-life care
* Death during ICU admission or during opioid IV infusion
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Suthinee Taesotikul
Principal investigator
Principal Investigators
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Suthinee Taesotikul, Pharm.D.
Role: PRINCIPAL_INVESTIGATOR
Faculty of Pharmacy, Mahidol university
Locations
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Faculty of Pharmacy, Mahidol University
Ratchathewi, Bangkok, Thailand
Countries
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References
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Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gelinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observational study. Ann Intensive Care. 2017 Sep 2;7(1):88. doi: 10.1186/s13613-017-0310-5.
Korak-Leiter M, Likar R, Oher M, Trampitsch E, Ziervogel G, Levy JV, Freye EC. Withdrawal following sufentanil/propofol and sufentanil/midazolam. Sedation in surgical ICU patients: correlation with central nervous parameters and endogenous opioids. Intensive Care Med. 2005 Mar;31(3):380-7. doi: 10.1007/s00134-005-2579-3. Epub 2005 Feb 16.
Brown C, Albrecht R, Pettit H, McFadden T, Schermer C. Opioid and benzodiazepine withdrawal syndrome in adult burn patients. Am Surg. 2000 Apr;66(4):367-70; discussion 370-1.
Cammarano WB, Pittet JF, Weitz S, Schlobohm RM, Marks JD. Acute withdrawal syndrome related to the administration of analgesic and sedative medications in adult intensive care unit patients. Crit Care Med. 1998 Apr;26(4):676-84. doi: 10.1097/00003246-199804000-00015.
Taesotikul S, Dilokpattanamongkol P, Tangsujaritvijit V, Suthisisang C. Incidence and clinical manifestation of iatrogenic opioid withdrawal syndrome in mechanically ventilated patients. Curr Med Res Opin. 2021 Jul;37(7):1213-1219. doi: 10.1080/03007995.2021.1928616. Epub 2021 May 25.
Other Identifiers
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10-60-68
Identifier Type: -
Identifier Source: org_study_id
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