Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Banner Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Banner Health
ClinicalTrials.gov Identifier:
NCT00792415
First received: November 17, 2008
Last updated: April 23, 2010
Last verified: December 2009

November 17, 2008
April 23, 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 ] [ Designated as safety issue: No ]
Reduction in the total days needed to wean methadone [ Time Frame: Up to 23 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00792415 on ClinicalTrials.gov Archive Site
Expert opinion on abstinence syndrome [ Time Frame: Up to 23 days ] [ Designated as safety issue: No ]
Abstinence syndrome symptoms scoring [ Time Frame: During and 72 hours after methadone administration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Pediatric Intensive Care Unit patients

Substance Withdrawal Syndrome
Not Provided
  • 1
    Limited continuous opioid exposure (at least 120 and less than 156 hours)
  • 2
    Extended continuous opioid exposure (156 hours or more)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
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
Both
up to 18 Years
No
Contact: Teri Reyburn-Orne, RN, MSN, PNP 480-512-3373 teri.reyburn-orne@bannerhealth.com
United States
 
NCT00792415
BHRI#05-08-0074
No
Teri Reyburn-Orne, RN, MSN, CPNP-AC/Pediatric Pain Team Program Manager, Cardon Children's Medical Center
Banner Health
Not Provided
Principal Investigator: Teri Reyburn-Orne, RN, MSN, PNP Banner Children's Hospital at Banner Desert Medical Center
Banner Health
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP