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Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults

NCT03435614 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2025-01-01

Study results available
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Summary

Mechanically ventilated critically ill adults may require prolonged administration of opioids to facilitate ventilator support and maintain comfort. The prolonged use has been associated with withdrawal symptoms upon rapid weaning in critically ill patients, known as the opioid-associated withdrawal syndrome (OIWS). Such withdrawal symptoms are well described in the paediatric population, however there is a lack of information in the adult population. Currently there is no bedside tool to rapidly identify such patients. Recognition of withdrawal symptoms is the basis for the development of an assessment tool to identify patients with OIWS.

Conditions

  • Substance Withdrawal Syndrome

Interventions

DRUG

Opioids

Once an opioid dose reduction of 10% or greater is achieved, a daily assessment will be conducted by a physician using the DSM-5 criteria for opioid withdrawal. In addition, signs and symptoms of withdrawal will be collected daily by a blinded investigator.

Sponsors & Collaborators

  • Marc M. Perreault

    lead OTHER

Principal Investigators

  • Marie-Soleil Delisle, MSc · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Marc M Perreault, PharmD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Marc-Alexandre Duceppe, MSc · McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03435614 on ClinicalTrials.gov