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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00792415
Other study ID # BHRI#05-08-0074
Secondary ID
Status Recruiting
Phase N/A
First received November 17, 2008
Last updated April 23, 2010
Start date November 2009
Est. completion date December 2010

Study information

Verified date December 2009
Source Banner Health
Contact Teri Reyburn-Orne, RN, MSN, PNP
Phone 480-512-3373
Email teri.reyburn-orne@bannerhealth.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date December 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Cardon Children's Medical Center Mesa Arizona

Sponsors (1)

Lead Sponsor Collaborator
Banner Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total scores of abstinence syndrome symptoms Up to 23 days No
Secondary Expert opinion on abstinence syndrome Up to 23 days No
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