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Impact of Low Dose Naloxone on Fentanyl Requirements in Pediatric ICU Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00286052
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : February 2, 2006
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:
Recently there has been an increased awareness in the need for adequate sedation and pain control for Pediatric Intensive Care Unit (ICU) patients. Fentanyl is an opioid commonly used in Pediatric ICU patients to decrease pain and increase sedation. Although opioids (e.g. morphine and fentanyl) provide excellent pain relief, they have many side effects including dependence, tolerance and withdrawal. These side effects lead to increased doses in order to maintain pain control and/or sedation. There have been a few adult studies pointing to some possible treatments. For example, giving low dose naloxone along with opioids. Adult studies show that this combination not only decreases the frequency of opioid side effects, but also improves pain control and prevents the development of tolerance. We propose that children who receive low dose naloxone infusions along with fentanyl infusions will demonstrate: 1) decreased total daily doses of Fentanyl, 2) decreased frequency of withdrawal and 3) increased pain and sedation control. In this randomized, blinded prospective trial we will enroll 168 Pediatric ICU patients. Patients will receive either low dose naloxone or placebo simultaneously with their fentanyl infusion. Pain and sedation will be assessed using the Modified Motor Activity Assessment Scale (MMAAS). The fentanyl infusion will be increased to provide adequate pain control and/or sedation. Naloxone infusion will not be adjusted. Approximately 48 hours prior to removal from the ventilator, patients will have their fentanyl infusions decreased while being monitored for withdrawal. Patients showing signs of withdrawal will receive methadone, an opioid taken by mouth. Once off fentanyl, naloxone will be stopped. Patients will continue to be monitored for withdrawal for 4 days or until ICU discharge. If this study works, patients who receive low dose naloxone along with opioid infusions will have less tolerance and dependence and demonstrate less withdrawal. This may cause shorter Intensive Care Unit stays.

Condition or disease Intervention/treatment Phase
Opioid Tolerance Drug: Low Dose Naloxone Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Impact of Concomitant Ultra Low Dose Infusion Naloxone and Therapeutic Infusion Opioid on Opioid Requirements in Pediatric ICU Patients
Study Start Date : December 2002
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Maximum Cummulative Daily Fentanyl Dose

Secondary Outcome Measures :
  1. Number of Rescue Fentanyl Boluses
  2. Number of Rescue Midazolam Boluses
  3. Total Midazolam Dose
  4. Narcotic Withdrawal Scale Score
  5. Modified Motor Activity Assessment Score

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Children age one (1) day to eighteen (18) years, requiring admission to the Pediatric ICU, requiring continuous infusion of Fentanyl analgesic anticipated to last greater than 4 days will be eligible for enrollment. Patients from both genders, all races and ethnic backgrounds will be eligible. Patients meeting the above criteria will be eligible regardless of nutritional status, performance status or recovery from prior medical treatment. They will not be excluded if they require simultaneous infusions of sedation with Midazolam. Enrollment will require parental consent.

Exclusion Criteria:

  • Patients will not be eligible if they meet any of the following criteria:
  • Patients who are currently on oral analgesia or sedation
  • Patients who have a prior history of drug or alcohol dependence/abuse.
  • History of significant or preexisting cardiovascular disease, they are receiving pro-arrhythmia medications, such as class I, II, III or IV antiarrhythmic agents.
  • Patients who are allergic to opioids or opioid antagonists.
  • Patients with documented chromosomal abnormality impairing perception of pain/discomfort.
  • Unable to obtain parental or legal guardian's informed consent
  • Concurrent admission to another study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00286052

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United States, Texas
Unversity of Texas Southwestern, Children's Medical Center, Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Cindy M Darnell University of Texas
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00286052    
Other Study ID Numbers: IRB File: 1002-605
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: February 2, 2006
Last Verified: September 2005
Additional relevant MeSH terms:
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Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents