Substance Withdrawal SyndromeNCT00792415
Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool
An observational study of Substance Withdrawal Syndrome, run by Banner Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks to 18 years
- Conditions the study is for
- Substance Withdrawal Syndrome
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric Intensive Care Unit patients
Who may be able to join
- 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
Who cannot join
- Attending discretion
- Patients with deterioration of medical status requiring interventions of pain control, surgery, sedation, or re-intubation
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardon Children's Medical Center
Mesa, Arizona, 85202
About this study
Official title: 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.
Read the detailed description
None available.
- Conditions
- Substance Withdrawal Syndrome
- Keywords
- Abstinence syndrome symptoms, Withdrawal symptoms, Opioid dependence
- Medical subject headings
- Substance Withdrawal Syndrome, Opioid-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Total scores of abstinence syndrome symptoms
None available - PI no longer with Banner
Measured: Up to 23 days
Secondary outcomes (1)
Expert opinion on abstinence syndrome
None available - PI no longer with Banner
Measured: Up to 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startNov 2009
- Primary completionApr 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Study doctor no longer with Banner Health, please remove this study from our list.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banner Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teri Reyburn-Orne, RN, MSN, PNP, Principal investigator, Banner Children's Hospital at Banner Desert Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792415
- Sponsor's protocol ID
- BHRI#05-08-0074
- Status last verified
- Feb 2025
- First submitted
- 17 Nov 2008
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Pediatric Abstinence Syndrome Scoring Tool Utilizing a Standardized Hospital-Based Guideline for Iatrogenic Opioid Dependence
- ClinicalTrials.gov ID
- NCT00792415
- Acronym / sponsor ID
- BHRI#05-08-0074
- Conditions
- Substance Withdrawal Syndrome
- Keywords
- Abstinence syndrome symptoms, Withdrawal symptoms, Opioid dependence
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study doctor no longer with Banner Health, please remove this study from our list.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Banner HealthUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 2 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric Intensive Care Unit patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Attending discretion
- Patients with deterioration of medical status requiring interventions of pain control, surgery, sedation, or re-intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total scores of abstinence syndrome symptoms
Time frame: Up to 23 days
None available - PI no longer with Banner
1 secondary outcome
Expert opinion on abstinence syndrome
Time frame: Up to 23 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teri Reyburn-Orne, RN, MSN, PNP principal investigator
Banner Children's Hospital at Banner Desert Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Withdrawal Syndrome, run by Banner Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total scores of abstinence syndrome symptoms (time frame: Up to 23 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.