Opioid Withdrawal Symptoms in Critically Ill Patients

Completed

• Conditions: Substance Withdrawal Syndrome; Critical Illness
• Interventions: Drug: Opioids

• Registration Number: NCT03374722
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-15
• Study Start: 2018-01-01
• Primary Completion: 2018-08-31
• Status Verified: 2018-10
• Study Completion: 2018-10-07
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanically ventilated critically ill patients	Opioids	Mechanically ventilated critically ill patients who receive opioid as continuous infusion for more than 24 hours

Primary Outcome Measures

Name	Time	Method
Incidence of opioid withdrawal symptoms	0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioid	Incidence of opioid withdrawal symptoms detected by self-developed assessment tool or the Diagnostic and Statistical Manual 5th edition (DSM-V)

Secondary Outcome Measures

Name	Time	Method
Weaning days	28 days	Time from initial weaning from mechanical ventilator until extubation
ICU length of stay	28 days	Time from admission to ICU until discharge from ICU
Ventilator days	28 days	Time from intubation until extubation

Trial Locations

Locations (1)

Faculty of Pharmacy, Mahidol University; 🇹🇭 Ratchathewi, Bangkok, Thailand