An observational study in Substance Withdrawal Syndrome and Critical Illness, sponsored by Mahidol University. Completed at 1 site in Thailand. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Mahidol University · Observational
Most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (ICU). Opioids are principal analgesics that alleviate moderate to severe pain and facilitate patients to co-operate the course of treatment. However, prolong administration of opioids especially in mechanically ventilated patients can cause withdrawal symptoms if analgesics are rapidly weaning or acutely disruption. The opioid withdrawal symptoms (OWS) are well reported in critically ill children that cause discomfort and prolong weaning from mechanical ventilation. Weaning opioids and treatment of withdrawal symptoms are needed in order to decrease ventilator days, ICU and hospital length of stay. Conversely, there is lack of knowledge about incidence, clinical presentation, time course and appropriated assessment tool for withdrawal detection. Therefore, we conduct the study to explore an incidence of OWS, to identify factors associated OWS, to establish the assessment tool for OWS, and to report efficacy of the pharmacological treatment for OWS, in adult critically ill patients.
The primary objective of the study is to explore incidence of OWS in adult critically ill patients. The secondary objectives are 1) to identify factor associated OWS, 2) establish the assessment tool for OWS for adults and 3) to report efficacy of the pharmacological treatment in OWS in adults patients.
74 studies on the registry are indexed under Substance Withdrawal Syndrome; 7 are open to participants now.
This study's enrollment of 55 is below the median of 115 across 15 observational studies indexed under Substance Withdrawal Syndrome.
Browse Substance Withdrawal Syndrome studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
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Intensive care units
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mechanically ventilated critically ill patients who receive opioid as continuous infusion for more than 24 hours
Drug: 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
Incidence of opioid withdrawal symptoms
Incidence of opioid withdrawal symptoms detected by self-developed assessment tool or the Diagnostic and Statistical Manual 5th edition (DSM-V)
Time frame: 0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioid
Weaning days
Time from initial weaning from mechanical ventilator until extubation
Time frame: 28 days
Ventilator days
Time from intubation until extubation
Time frame: 28 days
ICU length of stay
Time from admission to ICU until discharge from ICU
Time frame: 28 days
Ran from Jan 2018 to primary completion in Aug 2018, 7 months.
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Substance Withdrawal Syndrome →