Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool

April 23, 2010 updated by: Banner Health

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Recruiting
        • Cardon Children's Medical Center
        • Contact:
        • Sub-Investigator:
          • Tarek Youssef, MD, FAAP
        • Sub-Investigator:
          • Stephanie Nevins, MD
        • Sub-Investigator:
          • Keith Reitzel, MD
        • Sub-Investigator:
          • Rima Abdouni, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric Intensive Care Unit patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total scores of abstinence syndrome symptoms
Time Frame: Up to 23 days
Up to 23 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Expert opinion on abstinence syndrome
Time Frame: Up to 23 days
Up to 23 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banner Health

Investigators

  • Principal Investigator: Teri Reyburn-Orne, RN, MSN, PNP, Banner Children's Hospital at Banner Desert Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (Estimate)

November 18, 2008

Study Record Updates

Last Update Posted (Estimate)

April 26, 2010

Last Update Submitted That Met QC Criteria

April 23, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHRI#05-08-0074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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