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Adolescent Outcomes of Post-operative Opioid EXposure

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
SUMMARY

The goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with signposts of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• Adolescents between the ages of 12 to 17 years old, inclusive, who are scheduled to undergo a scheduled surgical procedure with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids.

• • Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis.

• Adolescents willing and able to provide informed assent and have a parent/caregiver willing to provide informed consent.

• Parent or legal guardian of an eligible adolescent.

• Parent or legal guardian willing and able to provide written informed consent.

Locations
United States
Colorado
Children's Hospital Colorado
NOT_YET_RECRUITING
Aurora
Florida
Johns Hopkins All Children's Hospital
NOT_YET_RECRUITING
St. Petersburg
Massachusetts
Boston Childrens Hopsital - Division of Addiction Medicine
RECRUITING
Boston
Ohio
Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
Contact Information
Primary
Sharon Levy, MD, MPH
sharon.levy@childrens.harvard.edu
857-218-4308
Backup
Joesph Cravero, MD
Joesph.Cravero@childrens.harvard.edu
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2028-02
Participants
Target number of participants: 20000
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
Leads: Sharon Levy

This content was sourced from clinicaltrials.gov