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

This study has been terminated.
(Naloxone became unavailable due to manufacturing shortatges requiring the study to be terminated.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00799201
First Posted: November 27, 2008
Last Update Posted: July 29, 2015
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.
Information provided by (Responsible Party):
Audis Bethea, Pharm.D., CAMC Health System
November 24, 2008
November 27, 2008
July 29, 2015
August 2007
October 2012   (Final data collection date for primary outcome measure)
Number of hours until first bowel movement [ Time Frame: While the patient is receiving continuous or scheduled narcotics ]
Same as current
Complete list of historical versions of study NCT00799201 on ClinicalTrials.gov Archive Site
  • Residual volume/toleration of feeds [ Time Frame: While the patient is receiving continuous or scheduled doses of narcotics ]
  • Average number of bowel movements per day [ Time Frame: While the patient is receiving continuous or scheduled narcotics ]
  • Escalation of opioid dose due to impaired analgesia [ Time Frame: While the patient is receiving study medications ]
Same as current
Not Provided
Not Provided
 
Enteral Naloxone Versus a Traditional Bowel Regimen for the Prevention of Opioid Induced Constipation in Trauma Patients
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
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Constipation
  • Analgesia
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
Experimental: Control
Sennosides liquid 5mL (8.8mg) every 6 hours plus docusate sodium liquid 10mL (100mg) every 12 hours
Intervention: Drug: Naloxone and Docusate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00799201
07-01-1897
Yes
Not Provided
Not Provided
Audis Bethea, Pharm.D., CAMC Health System
CAMC Health System
Not Provided
Principal Investigator: Audis Bethea, PharmD, BCPS CAMC Health System
CAMC Health System
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP