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

Study Overview
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Brief Summary
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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.

Official Title
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Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit

Conditions
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Opioid-induced Constipation

Intervention / Treatment
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* Drug: Methylnaltrexone Bromide
* Drug: Placebo-Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylnaltrexone Bromide<br> | Drug: Methylnaltrexone Bromide<br>* The experimental group will receive the recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs). Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg. If creatinine clearance <30 will decrease dose by 50%. This will be given after 72 hours of no bowel movement. Bowel management protocol will be instituted four hours afterward with the methylnaltrexone being given every other day.<br>* Other names: Relistor;|
| Placebo Comparator: Placebo<br> | Drug: Placebo-Normal Saline<br>* Control group will be given an equal amount of normal saline in an identically appearing vial every other day until a bowel movement occurs. A bowel management protocol will also be started.<br>* Other names: Relistor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes. |  | Nine months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo. |  | Nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit, Constipation, Bowel Management