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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Audis Bethea, Pharm.D., CAMC Health System
ClinicalTrials.gov Identifier:
NCT00799201
First received: November 24, 2008
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Constipation
Analgesia
Drug: Naloxone and Docusate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • Number of hours until first bowel movement [ Time Frame: While the patient is receiving continuous or scheduled narcotics ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Residual volume/toleration of feeds [ Time Frame: While the patient is receiving continuous or scheduled doses of narcotics ] [ Designated as safety issue: Yes ]
  • Average number of bowel movements per day [ Time Frame: While the patient is receiving continuous or scheduled narcotics ] [ Designated as safety issue: Yes ]
  • Escalation of opioid dose due to impaired analgesia [ Time Frame: While the patient is receiving study medications ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799201

Locations
United States, West Virginia
Charleston Area Medical Center, General Hospital
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Audis Bethea, PharmD, BCPS CAMC Health System
  More Information

Publications:

Responsible Party: Audis Bethea, Pharm.D., Clinical Pharmacy Specialist, Trauma/Surgery, CAMC Health System
ClinicalTrials.gov Identifier: NCT00799201     History of Changes
Other Study ID Numbers: 07-01-1897
Study First Received: November 24, 2008
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
Enteral nutrition
Constipation
Gastrointestinal motility
Naloxone
Docusate
Bowel stimulant
Stool softener

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Bismuth subsalicylate
Naloxone
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014