Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. John Health System, Michigan
• Treatments: Bromides; Methylnaltrexone; Naltrexone

Criteria

Inclusion Criteria:

• 18 years of age or older in the ICU

• Opioids for analgesia for at least 24 hours.

• Opioid-induced constipation with no bowel movement within the last 72 hours.

• Women of childbearing potential had negative pregnancy tests.

Exclusion Criteria:

• Contraindication to use of the GI tract

• Diarrhea on admission

• Bowel surgery within 8 weeks of admission

• Ileostomy or colostomy

• Not expected to live or stay more than 3 days in the intensive care unit

• Constipation that was not primarily caused by opioids (as determined by the investigator)

• No opioid use in the last 24 hours,

• Mechanical gastrointestinal obstruction

• An indwelling peritoneal catheter

• Clinically active diverticular disease

• Fecal impaction

• Acute surgical abdomen

• History of Crohn's disease or ulcerative colitis

• On Palliative care

• Less than 18 years old

• Bowel movement in last 72 hours.