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临床试验/NCT00799201
NCT00799201终止4 期

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

CAMC Health System1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
3
试验地点
1
主要终点
Number of hours until first bowel movement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnancy
  • < 18 years of age or > 65 years of age
  • Pancreatitis
  • 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

研究组 & 干预措施

Control

Experimental

Sennosides liquid 5mL (8.8mg) every 6 hours plus docusate sodium liquid 10mL (100mg) every 12 hours

干预措施: Naloxone and Docusate (Drug)

结局指标

主要结局

Number of hours until first bowel movement

时间窗: While the patient is receiving continuous or scheduled narcotics

次要结局

  • 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)

研究者

发起方
CAMC Health System
申办方类型
Other
责任方
Principal Investigator
主要研究者

Audis Bethea, Pharm.D.

Clinical Pharmacy Specialist, Trauma/Surgery

CAMC Health System

研究点 (1)

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