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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.
ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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

Study Design

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

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Teri Reyburn-Orne, RN, MSN, CPNP-AC/Pediatric Pain Team Program Manager, Cardon Children's Medical Center
ClinicalTrials.gov Identifier: NCT00792415     History of Changes
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:
Syndrome
Substance Withdrawal Syndrome
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents