Overview

Opioids Withdrawal Syndrome in Critically Ill Patients: a Multicenter Prospective Cohort Study

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
Critically ill patients who are mechanically ventilated may require prolonged administration of sedatives and analgesics. Their prolonged use has been associated with withdrawal symptoms upon rapid weaning in critically ill patients. These withdrawal symptoms may be associated with adverse clinical outcomes. Although well studied in the paediatric population, little is known about the epidemiology, risk factors and optimal screening methods in adults. Studying this problem is essential as we strive to develop proper weaning strategies. Methods: Prospective observational two-center study in critically ill adult patients Objectives: 1) Describe the incidence of iatrogenic withdrawal of sedatives and analgesics in critically ill adult patients and 2) Evaluate the performance of screening tools assessing withdrawal that were developed for the paediatric patient in the adult population.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hopital du Sacre-Coeur de Montreal
Treatments:
Analgesics
Narcotics
Criteria
Inclusion Criteria:

- intermittent use or continuous infusion opioids for at least 96 hours

Exclusion Criteria:

- Patient and/or relatives unable to communicate in French or English

- Patients unable to communicate (consent form and evaluation)

- Patient deaf without appropriate hearing aid

- Patients unable to communicate (consent form and evaluation)

- Imminent and predictable death 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 mm Hg) who requires ICP monitoring and osmotherapy

- Major confounding factors for withdrawal syndrome by causing shivering, sympathetic
drive and autonomic disorders

- Underlying active neurological condition (status epilepticus, encephalopathy, hypoxia)

- Neurological problems are covariates, which would make the assessment of sedation or
IWS difficult Patient previously included in the study at any of the two hospitals
(readmission to the ICU at a later date during the period of recruitment for the
study, limiting to 1 weaning episode per patient)

- Thoracic and cervical spinal cord injury

- Adrenergic response to pain will be difficult to assess

- Unable to assess validated tool: DSM-V, RASS, CAM-ICU

- Narcotic

- If the underlying neurological condition resolves within the 96 hours, the patient may
be included in the study

- Substance abuse prior to ICU admission (28)

- Chronic alcohol use defined as alcohol consumption of more than 2 drinks per day
and/or more than 14 drinks per week for men and 9 drinks per week for woman as
reported by family or as per patient's medical record