Status:
COMPLETED
Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults
Lead Sponsor:
Marc M. Perreault
Conditions:
Substance Withdrawal Syndrome
Eligibility:
All Genders
18+ years
Brief 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 withdraw...
Detailed Description
Objectives: 1. To identify specific signs and symptoms of OIWS in mechanically ventilated adult intensive care unit (ICU) patients receiving at least 72 hours of regular opioids at the Montreal Gener...
Eligibility Criteria
Inclusion
- Patients requiring mechanical ventilation and receiving continuous or regular intermittent opioids for at least 72 hours.
- Weaning of at least 10% from previous stable opioid dose. A weaning episode is defined as a ≥ 10% decrease in the total stable opioid dose received over 4 hours for opioid infusions and over 12 hours for intermittent opioid administration.
Exclusion
- Patient for whom consent cannot be obtained
- Patient and/or family unable to communicate in French or English
- Patient who is deaf without appropriate hearing aid
- Imminent and predictable death (\< 72 hours) according to medical team
- Severe brain injury, defined as Glasgow Coma Scale (GCS) score of 8 or less at ICU admission
- Moderate brain injury, defined as GCS between 9 and 12, with elevated intracranial pressure (ICP \> 20 mmHg) which requires ICP monitoring and osmotherapy
- Acute neurological condition (e.g. status epilepticus, encephalopathy, stroke). If the acute neurological condition resolves within 72 hours, the patient may be included in the study.
- Substance abuse prior to ICU admission.
- Chronic alcohol use defined as alcohol consumption of more than 2 drinks/day and/or more than 14 drinks/week for men and 9 drinks/week for women.
- Chronic use of illicit drugs and amphetamines (except amphetamines taken for therapeutic purposes) defined as a consumption of at least 3 times per week.
- Chronic use of opioids (e.g. transdermal fentanyl, methadone, hydromorphone, etc.) defined as a consumption of at least 3 times per week.
- Readmission to the MGH or RVH ICU during the recruitment period (limit of one study entry per patient)
- Spinal cord injury above the lumbar region
Key Trial Info
Start Date :
February 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03435614
Start Date
February 26 2018
End Date
September 30 2018
Last Update
January 1 2025
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1