Adjunct Methadone to Decrease the Duration of Mechanical Ventilation in the Medical Intensive Care Unit
Status:
Unknown status
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine if administering methadone to mechanically
ventilated patients in the medical intensive care unit (ICU) requiring continuous infusions
of sedatives and analgesics will decrease the time of mechanical ventilation, when initiated
within 48 hours of their admission. Patients meeting enrollment criteria will be randomly
assigned to receive methadone or placebo in addition to standard care. Methadone is a long
acting pain medication that is approved by the Food and Drug Administration (FDA) to manage
withdrawal from opioids and moderate to severe pain. Both of these indications are a frequent
concern for critically ill patients that require mechanical ventilation. These patients often
require intravenous (IV) opioids to manage the pain they experience due to their illness,
procedures, and mechanical ventilation. During this time patients can develop physical
dependence, which leads to withdrawal symptoms when the opioids are stopped or the dose is
reduced. These symptoms can include agitation, pain, diarrhea and several others. Currently
this is managed by a slow reduction in the dose of the IV opioid, but this can lead to
prolonged time on mechanical ventilation, which has been associated with increased morbidity.
Administering oral methadone to patients experiencing withdrawal symptoms has been shown to
reduce and even eliminate these symptoms in the outpatient setting. This should also benefit
patients in the ICU experiencing withdrawal from intravenous opioids required during their
stay. It may allow for the other opioids to be discontinued more quickly, allowing for a
shorter duration of mechanical ventilation.
The level of pain and sedation will be assessed between groups randomized to either methadone
or placebo in addition to current intravenous sedative and analgesic agents. The duration of
mechanical ventilation will be assessed between both groups. Opioid withdrawal symptoms may
manifest or be mistaken for delirium symptoms. ICU delirium is often managed with
antipsychotic medications. To assess if methadone can reduce the need for antipsychotic
medication, all administered antipsychotic doses will be recorded and total consumption will
be compared between the two groups. Methadone has been associated with abnormal heart rhythms
in rare instances. To ensure patient safety, data from the heart monitor will be collected
and compared between the two groups to assess for QT interval prolongation.