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

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00286052
First received: January 31, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Opioid Tolerance
Drug: Low Dose Naloxone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Maximum Cummulative Daily Fentanyl Dose

Secondary Outcome Measures:
  • Number of Rescue Fentanyl Boluses
  • Number of Rescue Midazolam Boluses
  • Total Midazolam Dose
  • Narcotic Withdrawal Scale Score
  • Modified Motor Activity Assessment Score

Estimated Enrollment: 128
Study Start Date: December 2002
Estimated Study Completion Date: August 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00286052

Locations
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
Investigators
Principal Investigator: Cindy M Darnell University of Texas
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00286052     History of Changes
Other Study ID Numbers: IRB File: 1002-605
Study First Received: January 31, 2006
Last Updated: January 31, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014