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

CAMC Health System

Status and phase

Terminated

Phase 4

Conditions

Analgesia

Constipation

Treatments

Drug: Naloxone and Docusate

Study type

Interventional

Funder types

Other

Identifiers

NCT00799201

07-01-1897

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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