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



Status:Terminated
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:August 2007
End Date:October 2012

Use our guide to learn which trials are right for you!

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.

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
We found this trial at
1
site
Charleston, West Virginia 25301
?
mi
from
Charleston, WV
Click here to add this to my saved trials