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Sponsored by: |
Banner Health |
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Information provided by: | Banner Health |
ClinicalTrials.gov Identifier: | NCT00792415 |
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 |
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Substance Withdrawal Syndrome |
Drug: Methadone |
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 |
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 |
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1
Extended continuous opioid exposure (156 hours or more)
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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.
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2
Limited continuous opioid exposure (at least 120 and less than 156 hours)
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Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Pediatric Intensive Care Unit patients
Inclusion Criteria:
Exclusion Criteria:
Contact: Teri Reyburn-Orne, RN, MSN, PNP | 480-512-3373 | teri.reyburn-orne@bannerhealth.com |
United States, Arizona | |
Banner Children's Hospital at Banner Desert Medical Center | |
Mesa, Arizona, United States, 85202 |
Principal Investigator: | Teri Reyburn-Orne, RN, MSN, PNP | Banner Children's Hospital at Banner Desert Medical Center |
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 |
Abstinence syndrome symptoms Withdrawal symptoms Opioid dependence |
Naphazoline Oxymetazoline Methadone Substance Withdrawal Syndrome Guaifenesin |
Phenylephrine Mental Disorders Substance-Related Disorders Disorders of Environmental Origin Phenylpropanolamine |
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 |