Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit
Phase 3
- Conditions
- Opioid-induced Constipation
- Interventions
- Drug: Placebo-Normal Saline
- Registration Number
- NCT01050595
- Lead Sponsor
- St. John Health System, Michigan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo-Normal Saline - Methylnaltrexone Bromide Methylnaltrexone Bromide -
- Primary Outcome Measures
Name Time Method A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes. Nine months
- Secondary Outcome Measures
Name Time Method Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo. Nine months
Trial Locations
- Locations (1)
Providence Hospital and Medical Center
🇺🇸Southfield, Michigan, United States