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

NCT00286052 | Completed Phase 3

• 1 other identifier: IRB File: 1002-605
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Tolerance

Outcome Measures

Primary Outcomes (1)

• Maximum Cummulative Daily Fentanyl Dose

Secondary Outcomes (5)

• Number of Rescue Fentanyl Boluses

• Number of Rescue Midazolam Boluses

• Total Midazolam Dose

• Narcotic Withdrawal Scale Score

• Modified Motor Activity Assessment Score

Interventions

Low Dose Naloxone DRUG

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Unversity of Texas Southwestern, Children's Medical Center, Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Darnell CM, Thompson J, Stromberg D, Roy L, Sheeran P. Effect of low-dose naloxone infusion on fentanyl requirements in critically ill children. Pediatrics. 2008 May;121(5):e1363-71. doi: 10.1542/peds.2007-1468. Epub 2008 Apr 14.

  PMID: 18411237 DERIVED

MeSH Terms

Interventions

Naloxone

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Cindy M Darnell

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: December 1, 2002
• Study Completion: August 1, 2004
• Last Updated: February 2, 2006

Record last verified: 2005-09

Locations

US (1)