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Study of Methadone for Management of Iatrogenic Opioid Dependence in Critical Care Children
This study is not yet open for participant recruitment.
Verified by Banner Health, November 2008
Sponsored by: Banner Health
Information provided by: Banner Health
ClinicalTrials.gov Identifier: NCT00792415
  Purpose

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.


Condition Intervention
Substance Withdrawal Syndrome
Drug: Methadone

MedlinePlus related topics: Children's Health Critical Care
Drug Information available for: Methadone Methadone hydrochloride
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: The Efficacy of a Standardized Methadone Weaning Protocol Utilizing an Abstinence Syndrome Scoring Tool Specific for Pediatrics

Further study details as provided by Banner Health:

Primary Outcome Measures:
  • Reduction in the total days needed to wean methadone [ Time Frame: Up to 23 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Abstinence syndrome symptoms scoring [ Time Frame: During and 72 hours after methadone administration ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Extended continuous opioid exposure (156 hours or more)
Drug: Methadone
Patients will be placed into a 5-, 10-, or 20-day methadone wean, as dictated by the length of exposure to continuous opioid infusions, which has been established by a standardized methadone wean protocol. Methadone dosing will be individualized and initial dosing will be equipotent to previously administered continuous opioid infusions. Methadone will be given orally and/or intravenously every 12 hours.
2
Limited continuous opioid exposure (at least 120 and less than 156 hours)

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric Intensive Care Unit patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792415

Contacts
Contact: Teri Reyburn-Orne, RN, MSN, PNP 480-512-3373 teri.reyburn-orne@bannerhealth.com

Locations
United States, Arizona
Banner Children's Hospital at Banner Desert Medical Center
Mesa, Arizona, United States, 85202
Sponsors and Collaborators
Banner Health
Investigators
Principal Investigator: Teri Reyburn-Orne, RN, MSN, PNP Banner Children's Hospital at Banner Desert Medical Center
  More Information

Responsible Party: Banner Children's Hospital at Banner Desert Medical Center ( Teri Reyburn-Orne, RN, MSN, CPNP-AC/Pediatric Pain Team Program Manager )
Study ID Numbers: BHRI#05-08-0074
Study First Received: November 17, 2008
Last Updated: November 17, 2008
ClinicalTrials.gov Identifier: NCT00792415  
Health Authority: United States: Institutional Review Board

Keywords provided by Banner Health:
Abstinence syndrome symptoms
Withdrawal symptoms
Opioid dependence

Study placed in the following topic categories:
Naphazoline
Oxymetazoline
Methadone
Substance Withdrawal Syndrome
Guaifenesin
Phenylephrine
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Phenylpropanolamine

Additional relevant MeSH terms:
Respiratory System Agents
Disease
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Pathologic Processes
Sensory System Agents
Syndrome
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 15, 2009