Status:
TERMINATED
Enteral Naloxone Versus a Traditional Bowel Regimen for the Prevention of Opioid Induced Constipation in Trauma Patients
Lead Sponsor:
CAMC Health System
Conditions:
Constipation
Analgesia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 critic...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00799201
Start Date
August 1 2007
End Date
October 1 2012
Last Update
July 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charleston Area Medical Center, General Hospital
Charleston, West Virginia, United States, 25301