N/A
N=29
Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults
Substance Withdrawal Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03435614 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Description of Signs and Symptoms of OIWS in Patients Who Scored Positive for Withdrawal Syndrome (OIWS) According to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criteria — 28.6; 13.6; 28.6; 4.9 percentage of assessments
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Opioids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Marc M. Perreault
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Description of Signs and Symptoms of OIWS in Patients Who Scored Positive for Withdrawal Syndrome (OIWS) According to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criteria |
28.6; 13.6; 28.6; 4.9; 57.1; 30.6 | — |
| SECONDARY Change in Serum Cortisol Level |
-146; -37 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 ( 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
Data sourced from ClinicalTrials.gov (NCT03435614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.