Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit
| Status: | Completed |
|---|---|
| Conditions: | Constipation |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2009 |
| End Date: | December 2010 |
| Contact: | Bradford A Whitmer, D.O. |
| Email: | whitmer5@msu.edu |
| Phone: | 2482891272 |
Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit
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.
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.
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.
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