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Completed

NCT Number: NCT03374722

Opioid Withdrawal Symptoms in Critically Ill Patients

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.

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Key information

Conditions

Substance Withdrawal Syndrome Chemically-Induced Disorders Critical Illness Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Pharmacy, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioids

Drug

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

Primary outcomes

  1. Incidence of opioid withdrawal symptoms

    Time frame: 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 outcomes

  1. Weaning days

    Time frame: 28 days

    Time from initial weaning from mechanical ventilator until extubation

  2. Ventilator days

    Time frame: 28 days

    Time from intubation until extubation

  3. ICU length of stay

    Time frame: 28 days

    Time from admission to ICU until discharge from ICU

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2017
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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