NCT00792415

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

November 17, 2008

Last Update Submit

February 7, 2025

Conditions

Substance Withdrawal Syndrome

Keywords

Abstinence syndrome symptomsWithdrawal symptomsOpioid dependence

Outcome Measures

Primary Outcomes (1)

  • Total scores of abstinence syndrome symptoms

    None available - PI no longer with Banner

    Up to 23 days

Secondary Outcomes (1)

  • Expert opinion on abstinence syndrome

    Up to 23 days

Eligibility Criteria

Age2 Weeks - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric Intensive Care Unit patients

You may qualify if:

  • 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

You may not qualify if:

  • Attending discretion
  • Patients with deterioration of medical status requiring interventions of pain control, surgery, sedation, or re-intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardon Children's Medical Center

Mesa, Arizona, 85202, United States

Location

MeSH Terms

Conditions

Substance Withdrawal SyndromeOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Study Officials

  • Teri Reyburn-Orne, RN, MSN, PNP

    Banner Children's Hospital at Banner Desert Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 18, 2008

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

December 1, 2010

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations

US(1)