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Opioid Withdrawal Symptoms in Critically Ill Patients

Opioid Withdrawal Symptoms in Critically Ill Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03374722
Enrollment
55
Registered
2017-12-15
Start date
2018-01-01
Completion date
2018-10-07
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Substance Withdrawal Syndrome

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.

Interventions

DRUGOpioids

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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of opioid withdrawal symptoms0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioidIncidence of opioid withdrawal symptoms detected by self-developed assessment tool or the Diagnostic and Statistical Manual 5th edition (DSM-V)

Secondary

MeasureTime frameDescription
Weaning days28 daysTime from initial weaning from mechanical ventilator until extubation
Ventilator days28 daysTime from intubation until extubation
ICU length of stay28 daysTime from admission to ICU until discharge from ICU

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026