|
| |
|
| Daily use of a scheduled opioid (≥100 MME) or methadone at any dose in the week prior to ICU admission |
| History of constipation as defined by the scheduled use of bisacodyl, senna, lactulose, PEG 3350 (MiraLAX®), and/or saline enema (Fleet® saline enema) prior to ICU admission |
| Current scheduled use of a medication affecting gastric motility (e.g., metoclopramide, domperidone, erythromycin, and loperamide) |
| Acute GI condition (e.g., clinical evidence of acute fecal impaction or complete obstruction, acute surgical abdomen, and acute GI bleeding) |
| Chronic or acute condition affecting GI motility or function (e.g., inflammatory bowel disease requiring immunosuppressive therapy, symptomatic clostridium difficile, active diverticular disease, and surgery on the colon or abdomen within 60 days of ICU admission) |
| Current or previous use of an opioid antagonist agent (e.g., naloxegol and methylnaltrexone) in the past 30 days |
| Current use of total parenteral nutrition |
| Current use of a medication known to be a strong CYP3A4 inhibitor (e.g., itraconazole, ketoconazole, voriconazole, lopinavir/ritonavir, indinavir/ritonavir, ritonavir, clarithromycin, nefazodone) |
| Current use of a medication known to be a strong CYP3A4 inducer (e.g., rifampin, carbamazepine, St. John’s wort) |
| Known serious or severe hypersensitivity to Movantik® (naloxegol) or any of its excipients |
| Severe hepatic dysfunction, defined as (i) INR ≥2.0 (not related to warfarin therapy) and total bilirubin ≥2 or (ii) diagnosis of liver cirrhosis defined by child-pugh class B or C, or (iii) acute liver disease is the primary reason for current ICU admission |
| Chronic or acute neurologic condition that may affect the permeability of the blood-brain barrier (e.g., multiple sclerosis, recent brain injury, Alzheimer’s disease, uncontrolled epilepsy, acute stroke, and acute meningitis) |
| Underlying cancer associated with heightened risk of GI perforation (e.g., underlying malignancies of the GI tract or peritoneum, recurrent or advanced ovarian cancer, and vascular endothelial growth factor inhibitor treatment) |
| Administration of enteral nutrition through a jejunal tube |
| Unreliable method for enteral, gastric, or oral medication administration (e.g., no feeding tube and NG tube on suction) |
| Inability to enrol and initiate study medication within 72 hours of first initiating IV opioid therapy in the ICU |
| Patients expected to expire within 24 hours |
| Pregnant or actively lactating females |
| Current participation in another interventional clinical study |
| Inability to obtain informed consent from either the patient or their legally authorized representative |
| Medical ICU or attending physician objection to patient enrolment |
|
