The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.
Opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. Not only are the medical complications potentially severe, patient quality of life can also be impacted. Two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. Mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. The literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
Methylnaltrexone Bromide 150 mg Oral Tablet
Methylnaltrexone Bromide 12 MG Subcutaneous Solution
Naloxegol 25 MG Oral Tablet
Kara B. Goddard
Columbia, Missouri, United States
Occurrence of Bowl Movement
The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.
Time frame: 24 hours
Time to Bowl Movement Within 24 Hours
The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.
Time frame: 24 hours after administration of study drug
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