Adjunct Methadone to Decrease the Duration of Mechanical Ventilation in the Medical Intensive Care Unit
Opioid Use, Unspecified With Withdrawal, Opioid-Induced Disorders, Delirium
About this trial
This is an interventional treatment trial for Opioid Use, Unspecified With Withdrawal focused on measuring Iatrogenic opioid abstinence syndrome, Methadone, Mechanical ventilation, ICU delirium, Continuous sedation
Eligibility Criteria
Inclusion Criteria:
- Mechanically ventilated patients with opioid consumption greater than or equal to 1,200 mcg of fentanyl or equivalent consumption of another opioid per day during the first 48 hours of intubation.
Exclusion Criteria:
- Allergy to methadone
- Admitted for head injury
- Admitted for seizure
- Seizure during admission, prior to enrollment
- Subjects at high risk for developing a prolonged corrected QT (QTc) interval
- Gastric residual volume ≥200 mL
- Suspected obstruction or ileus
- Nausea and vomiting
- Recent abdominal surgery
- Active upper or lower gastrointestinal bleeding
- Active order for no medications by mouth or Total parenteral nutrition (TPN)
- Pregnancy
- Subjects receiving neuromuscular blocker infusions
- Subjects taking antipsychotics at baseline
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Methadone
Placebo
Methadone will be administered at a dose calculated from the subjects total daily opioid requirements, with a maximum methadone dose of 60 mg per day. The methadone will be administered every 8 hours as 5 mg capsules that will be given via an enteral feeding tube.
This will be a capsule containing only lactose and will be given every 8 hours via an enteral feeding tube. The number of placebo capsules will be calculated based on the subjects opioid requirements. This will ensure the same number of capsules will be given despite which arm the patient is enrolled in.