Working… Menu

Enteral Naloxone Versus a Traditional Bowel Regimen for the Prevention of Opioid Induced Constipation in Trauma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00799201
Recruitment Status : Terminated (Naloxone became unavailable due to manufacturing shortatges requiring the study to be terminated.)
First Posted : November 27, 2008
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):
Audis Bethea, Pharm.D., CAMC Health System

Brief Summary:
The purpose of this study is to determine if enteral naloxone is more effective than a traditional bowel regimen in the prevention and treatment of constipation and impaired gastric motility in critically ill trauma patients.

Condition or disease Intervention/treatment Phase
Constipation Analgesia Drug: Naloxone and Docusate Phase 4

Detailed Description:

Impaired gastric motility and constipation are common issues among patients in the intensive care setting. Contributing factors include trauma, multiple surgical procedures, lack of ambulation, and the use of opiate analgesics to control pain. Common treatments for altered gastric motility and constipation include administration of pro-motility agents, stool softeners and bowel stimulants.

Enteral feeding is considered the safest and most effective way to provide nutrition to critically ill patients. Nutrition can be delayed and/or held when impaired gastric motility and constipation are present. Studies suggest that delays in the administration of nutrition can lead to prolonged ventilator time and increased length of stay in the intensive care setting as well as an increase in mortality.

Naloxone, a competitive opioid antagonist, is most commonly administered systemically to counteract the central and peripheral effects of opioids. When administered enterally naloxone has also been found to increase gastric emptying. Studies in patients receiving enteral feeds with multiple risk factors for altered gastric motility and constipation suggest that administration of enteral naloxone can reduce the incidence and extent of altered gastric motility and aid in defecation while not totally reversing the systemic effects of the opiate being administered. Due to these findings, it appears that enterally administered naloxone would provide a significant advantage over traditional gastrointestinal stimulants in preventing constipation in critically ill patients receiving continuous administration of opiate analgesics. In addition, the use of an enterally administered opiate antagonist may also alleviate the need for routine administration of pro-kinetic agents in order to promote adequate gastrointestinal motility and toleration of enterally administered nutrition. As a result, the comparison of enteral naloxone plus a stool softener versus a traditional bowel regimen containing a stimulant and stool softener will aid in assessing the effectiveness of opiate reversal locally in the gastrointestinal tract in prevention of decreased gastric motility and constipation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized Trial of Enteral Naloxone Versus a Traditional Bowel Regimen in Prevention of Constipation and Decreased Gastric Motility in Critically Ill Trauma Patients
Study Start Date : August 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: Control
Sennosides liquid 5mL (8.8mg) every 6 hours plus docusate sodium liquid 10mL (100mg) every 12 hours
Drug: Naloxone and Docusate
Naloxone 6mg (15 mL) every 6 hours plus docusate sodium liquid 10 mL (100mg) every 12 hours
Other Names:
  • Narcan
  • Colace

Primary Outcome Measures :
  1. Number of hours until first bowel movement [ Time Frame: While the patient is receiving continuous or scheduled narcotics ]

Secondary Outcome Measures :
  1. Residual volume/toleration of feeds [ Time Frame: While the patient is receiving continuous or scheduled doses of narcotics ]
  2. Average number of bowel movements per day [ Time Frame: While the patient is receiving continuous or scheduled narcotics ]
  3. Escalation of opioid dose due to impaired analgesia [ Time Frame: While the patient is receiving study medications ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and non-pregnant females > 18 years of age and < 65 years of age
  • MSICU admission to the trauma service at the General Hospital
  • Scheduled for continuous infusion/administration of opiate analgesics for at least 24 hours
  • Access for enteral administration of medications and tube feeds
  • Initiation of tube feeds

Exclusion Criteria:

  • NPO
  • Pregnancy
  • < 18 years of age or > 65 years of age
  • Pancreatitis
  • Ileus
  • Large bowel obstruction present on plain X-ray or CT scan
  • Recent intestinal anastomosis (within 2 weeks)
  • Section of large bowel removed (within 2 weeks)
  • Contraindications to metaclopramide (Reglan) such as parkinson's disease, tardive dyskinesia, etc.
  • Traumatic brain injury with a glasgow coma score of at least 8
  • Use of pharmacologic paralytics or neuromuscular blockade (NMB)
  • Non-english speaking patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00799201

Layout table for location information
United States, West Virginia
Charleston Area Medical Center, General Hospital
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
CAMC Health System
Layout table for investigator information
Principal Investigator: Audis Bethea, PharmD, BCPS CAMC Health System

Layout table for additonal information
Responsible Party: Audis Bethea, Pharm.D., Clinical Pharmacy Specialist, Trauma/Surgery, CAMC Health System Identifier: NCT00799201    
Other Study ID Numbers: 07-01-1897
First Posted: November 27, 2008    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Keywords provided by Audis Bethea, Pharm.D., CAMC Health System:
Enteral nutrition
Gastrointestinal motility
Bowel stimulant
Stool softener
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents