Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792415
Recruitment Status : Unknown
Verified December 2009 by Banner Health.
Recruitment status was:  Recruiting
First Posted : November 18, 2008
Last Update Posted : April 26, 2010
Information provided by:
Banner Health

November 17, 2008
November 18, 2008
April 26, 2010
November 2009
April 2010   (Final data collection date for primary outcome measure)
Total scores of abstinence syndrome symptoms [ Time Frame: Up to 23 days ]
Reduction in the total days needed to wean methadone [ Time Frame: Up to 23 days ]
Complete list of historical versions of study NCT00792415 on Archive Site
Expert opinion on abstinence syndrome [ Time Frame: Up to 23 days ]
Abstinence syndrome symptoms scoring [ Time Frame: During and 72 hours after methadone administration ]
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Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool
Validation of a Pediatric Abstinence Syndrome Scoring Tool Utilizing a Standardized Hospital-Based Guideline for Iatrogenic Opioid Dependence
The purpose of this study is to assess the validity and reliability of an abstinence syndrome assessment tool used in pediatric patients with iatrogenic opioid dependence.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Pediatric Intensive Care Unit patients
Substance Withdrawal Syndrome
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  • 1
    Limited continuous opioid exposure (at least 120 and less than 156 hours)
  • 2
    Extended continuous opioid exposure (156 hours or more)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2010
April 2010   (Final data collection date for primary outcome measure)

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
  • Patients with deterioration of medical status requiring interventions of pain control, surgery, sedation, or re-intubation
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Teri Reyburn-Orne, RN, MSN, CPNP-AC/Pediatric Pain Team Program Manager, Cardon Children's Medical Center
Banner Health
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Principal Investigator: Teri Reyburn-Orne, RN, MSN, PNP Banner Children's Hospital at Banner Desert Medical Center
Banner Health
December 2009