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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Constipation, Analgesia

Intervention / Treatment
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* Drug: Naloxone and Docusate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Sennosides liquid 5mL (8.8mg) every 6 hours plus docusate sodium liquid 10mL (100mg) every 12 hours | Drug: Naloxone and Docusate<br>* Naloxone 6mg (15 mL) every 6 hours plus docusate sodium liquid 10 mL (100mg) every 12 hours<br>* Other names: Colace;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hours until first bowel movement |  | While the patient is receiving continuous or scheduled narcotics | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual volume/toleration of feeds |  | While the patient is receiving continuous or scheduled doses of narcotics | 
| Average number of bowel movements per day |  | While the patient is receiving continuous or scheduled narcotics | 
| Escalation of opioid dose due to impaired analgesia |  | While the patient is receiving study medications | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral nutrition, Constipation, Gastrointestinal motility, Naloxone, Docusate, Bowel stimulant, Stool softener