Opioid Withdrawal Symptoms in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Opioid Withdrawal Symptoms in Critically Ill Patients

Conditions
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Substance Withdrawal Syndrome, Critical Illness

Intervention / Treatment
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* Drug: Opioids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years 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: Severely disturbed behavior pattern on account of underlying neurological disease (status epilepticus, encephalopathy, head trauma, brain injury, spinal cord injury) 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mechanically ventilated critically ill patients<br>Mechanically ventilated critically ill patients who receive opioid as continuous infusion for more than 24 hours | Drug: Opioids<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning days | Time from initial weaning from mechanical ventilator until extubation | 28 days | 
| Ventilator days | Time from intubation until extubation | 28 days | 
| ICU length of stay | Time from admission to ICU until discharge from ICU | 28 days |