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Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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: 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

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 ]

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   (Child, Adult)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792415

Locations
United States, Arizona
Cardon Children's Medical Center
Mesa, Arizona, United States, 85202
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 
Study First Received: November 17, 2008
Last Updated: April 23, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 09, 2016