Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool

This study is currently recruiting participants.

Verified by Banner Health, December 2009

First Received: November 17, 2008 Last Updated: December 10, 2009 History of Changes

Sponsor:	Banner Health
Information provided by:	Banner Health
ClinicalTrials.gov Identifier:	NCT00792415

Purpose

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.

Condition
Substance Withdrawal Syndrome

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Validation of a Pediatric Abstinence Syndrome Scoring Tool Utilizing a Standardized Hospital-Based Guideline for Iatrogenic Opioid Dependence

Further study details as provided by Banner Health:

Primary Outcome Measures:

Total scores of abstinence syndrome symptoms [ Time Frame: Up to 23 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Expert opinion on abstinence syndrome [ Time Frame: Up to 23 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	75
Study Start Date:	November 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Limited continuous opioid exposure (at least 120 and less than 156 hours)
2 Extended continuous opioid exposure (156 hours or more)

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
Patients with deterioration of medical status requiring interventions of pain control, surgery, 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
Cardon Children's Medical Center	Recruiting
Mesa, Arizona, United States, 85202
Contact: Teri Reyburn-Orne, RN, MSN, PNP 480-512-7901 teri.reyburn-orne@bannerhealth.com
Sub-Investigator: Tarek Youssef, MD, FAAP
Sub-Investigator: Stephanie Nevins, MD
Sub-Investigator: Keith Reitzel, MD
Sub-Investigator: Rima Abdouni, PharmD

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

No publications provided

Responsible Party:	Cardon Children's 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:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00792415 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Banner Health:

Abstinence syndrome symptoms
Withdrawal symptoms
Opioid dependence

Additional relevant MeSH terms:

Pathologic Processes
Disease
Substance Withdrawal Syndrome
Mental Disorders

Syndrome
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on February 09, 2010