Validation of a Pediatric-Specific Abstinence Syndrome As... | NCT00792415

Studies
Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool

NCT00792415

Sponsor

Banner Health

Status

Withdrawn

Last Update Posted

Feb 11, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Substance Withdrawal Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study doctor no longer with Banner Health, please remove this study from our list.

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Apr 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Nov 17, 2008

First Submission Date that Met QC Criteria

Nov 17, 2008

First Posted Date

Nov 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2025

Last Update Posted Date

Feb 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

None available.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total scores of abstinence syndrome symptoms	None available - PI no longer with Banner	Up to 23 days

Secondary Outcomes

Measure	Description	Time Frame
Expert opinion on abstinence syndrome	None available - PI no longer with Banner	Up to 23 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric Intensive Care Unit patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Teri Reyburn-Orne, RN, MSN, PNP	Banner Children's Hospital at Banner Desert Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardon Children's Medical Center		Mesa	Arizona	85202	United States

Condition Browse Module

MeSH Terms

ID	Term
D013375	Substance Withdrawal Syndrome
D009293	Opioid-Related Disorders

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D000079524	Narcotic-Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided