Study of Methadone for Management of Iatrogenic Opioid Dependence in Critical Care Children
Information source: Banner Health
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Substance Withdrawal Syndrome
Intervention: Methadone (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Banner Health Official(s) and/or principal investigator(s):
Teri Reyburn-Orne, RN, MSN, PNP, Principal Investigator, Affiliation: Banner Children's Hospital at Banner Desert Medical Center
Overall contact:
Teri Reyburn-Orne, RN, MSN, PNP, Phone: 480-512-3373, Email: teri.reyburn-orne@bannerhealth.com
Summary
The purpose of this study is to examine the efficacy of a standardized methadone weaning
treatment protocol and whether it leads to a reduction in the total number of days needed to
wean opioids after prolonged exposure. The use of this protocol may also promote a reduction
in abstinence syndrome symptoms. Patients will be converted from continuous intravenous
opioid infusions to one of three methadone dosing schedules. Initial methadone dose
conversion will be equipotent to the previously administered continuous intravenous opioid
infusion. Subsequently, a methadone weaning schedule will follow according to the guidelines
set forth by the Methadone Wean Protocol Also, concurrent validity and reliability testing
will be performed on the Pediatric Abstinence Syndrome Scoring Sheet, which is a
pediatric-specific abstinence syndrome assessment tool.
To assure consistency and compliance to the protocol, a standardized physician's order form
for methadone wean was developed. This order form includes a step-by-step calculation
approach for conversion from continuous opioid to intermittent methadone.
Clinical Details
Official title: The Efficacy of a Standardized Methadone Weaning Protocol Utilizing an Abstinence Syndrome Scoring Tool Specific for Pediatrics
Study design: Case Control, Prospective
Primary outcome: Reduction in the total days needed to wean methadone
Secondary outcome: Abstinence syndrome symptoms scoring
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pediatric Intensive Care Unit patients ages 2 weeks to 18 years
- Patients receiving continuous opioid infusions for 5 days (at least 120 hours) or
more
Exclusion Criteria:
- Attending discretion
- Any deviation from the protocol
- Patients requiring acute surgical interventions during the study period
- Patients with deterioration of medical status requiring interventions of pain control,
sedation, or re-intubation
Locations and Contacts
Teri Reyburn-Orne, RN, MSN, PNP, Phone: 480-512-3373, Email: teri.reyburn-orne@bannerhealth.com
Banner Children's Hospital at Banner Desert Medical Center, Mesa, Arizona 85202, United States
Additional Information
Starting date: January 2009
Ending date: December 2009
Last updated: January 28, 2009
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