COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

Brief Summary:
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 or disease
Substance Withdrawal Syndrome

Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Pediatric Abstinence Syndrome Scoring Tool Utilizing a Standardized Hospital-Based Guideline for Iatrogenic Opioid Dependence
Study Start Date : November 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Limited continuous opioid exposure (at least 120 and less than 156 hours)
Extended continuous opioid exposure (156 hours or more)

Primary Outcome Measures :
  1. Total scores of abstinence syndrome symptoms [ Time Frame: Up to 23 days ]

Secondary Outcome Measures :
  1. Expert opinion on abstinence syndrome [ Time Frame: Up to 23 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric Intensive Care Unit patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792415

Layout table for location contacts
Contact: Teri Reyburn-Orne, RN, MSN, PNP 480-512-3373

Layout table for location information
United States, Arizona
Cardon Children's Medical Center Recruiting
Mesa, Arizona, United States, 85202
Contact: Teri Reyburn-Orne, RN, MSN, PNP    480-512-7901   
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
Layout table for investigator information
Principal Investigator: Teri Reyburn-Orne, RN, MSN, PNP Banner Children's Hospital at Banner Desert Medical Center

Layout table for additonal information
Responsible Party: Teri Reyburn-Orne, RN, MSN, CPNP-AC/Pediatric Pain Team Program Manager, Cardon Children's Medical Center Identifier: NCT00792415    
Other Study ID Numbers: BHRI#05-08-0074
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: April 26, 2010
Last Verified: December 2009
Keywords provided by Banner Health:
Abstinence syndrome symptoms
Withdrawal symptoms
Opioid dependence
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance Withdrawal Syndrome
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents