Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit
NCT ID: NCT01050595
Last Updated: 2010-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2009-12-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Methylnaltrexone Bromide
Methylnaltrexone Bromide
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.
Placebo
Placebo-Normal Saline
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.
Interventions
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Methylnaltrexone Bromide
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.
Placebo-Normal Saline
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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St. John Health System, Michigan
OTHER
Responsible Party
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Providence Medical Center and Hospital
Principal Investigators
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Bradford A Whitmer, D.O.
Role: PRINCIPAL_INVESTIGATOR
Providence Hospital and Medical Center
Locations
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Providence Hospital and Medical Center
Southfield, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Ritchie G, Burgess L, Mostafa S, Wenstone R. Preventing constipation in critically ill patients. Nurs Times. 2008 Nov 18-24;104(46):42-4.
Patanwala AE, Abarca J, Huckleberry Y, Erstad BL. Pharmacologic management of constipation in the critically ill patient. Pharmacotherapy. 2006 Jul;26(7):896-902. doi: 10.1592/phco.26.7.896.
Chappell D, Rehm M, Conzen P. Opioid-induced constipation in intensive care patients: relief in sight? Crit Care. 2008;12(4):161. doi: 10.1186/cc6930. Epub 2008 Jul 1.
Mostafa SM, Bhandari S, Ritchie G, Gratton N, Wenstone R. Constipation and its implications in the critically ill patient. Br J Anaesth. 2003 Dec;91(6):815-9. doi: 10.1093/bja/aeg275.
Tittle M, McMillan SC. Pain and pain-related side effects in an ICU and on a surgical unit: nurses' management. Am J Crit Care. 1994 Jan;3(1):25-30.
Viscusi ER, Gan TJ, Leslie JB, Foss JF, Talon MD, Du W, Owens G. Peripherally acting mu-opioid receptor antagonists and postoperative ileus: mechanisms of action and clinical applicability. Anesth Analg. 2009 Jun;108(6):1811-22. doi: 10.1213/ane.0b013e31819e0d3a.
Arpino PA, Thompson BT. Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit. J Clin Pharm Ther. 2009 Apr;34(2):171-5. doi: 10.1111/j.1365-2710.2008.00982.x.
McKenna S, Wallis M, Brannelly A, Cawood J. The nursing management of diarrhoea and constipation before and after the implementation of a bowel management protocol. Aust Crit Care. 2001 Feb;14(1):10-6. doi: 10.1016/s1036-7314(01)80017-5.
Dorman BP, Hill C, McGrath M, Mansour A, Dobson D, Pearse T, Singleton J, Al-Omoush A, Barry M, Colongon AR, Perez M, Fitzgerald D, Zabala M. Bowel management in the intensive care unit. Intensive Crit Care Nurs. 2004 Dec;20(6):320-9. doi: 10.1016/j.iccn.2004.09.004.
Hill S, Anderson J, Baker K, Bonson B, Gager M, Lake E. Management of constipation in the critically ill patient. Nurs Crit Care. 1998 May-Jun;3(3):134-7.
Sanz Rubiales A, del Valle Rivero ML. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008 Sep 4;359(10):1070-1; author reply 1071. doi: 10.1056/NEJMc081373. No abstract available.
Other Identifiers
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107199
Identifier Type: -
Identifier Source: org_study_id
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