Actively Recruiting
Adolescent Outcomes of Post-operative Opioid Exposure
Led by Sharon Levy · Updated on 2026-03-18
20000
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sharon Levy
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adolescents aged 12 to 17 who undergo major surgery and receive opioids for pain management. The study aims to identify factors linked to the risk of developing opioid use disorder (OUD) within 12 months after surgery. This observational research collects information from adolescents and their parents to better understand how opioid exposure after surgery may lead to future OUD. The study gathers data from 10,000 adolescent-parent pairs, focusing on those scheduled for surgery with planned opioid use for at least 48 hours after the procedure. Participants complete electronic surveys before and after surgery, and researchers collect related medical record information. The study uses this combined data to explore patterns of opioid use and pain following surgery, aiming to develop screening tools and improve pain management protocols for adolescents. During the study, adolescents and their parents provide survey responses and allow access to peri-operative medical records. Researchers analyze this information to measure risks of opioid use disorder related to prolonged pain, opioid use, non-medical opioid use, changes in substance use, and surgical trauma over a 12-month period. This study helps to create new methods for assessing risk and guides future care recommendations to support safer pain treatment in youth after surgery.
CONDITIONS
Brief Title
Adolescent Outcomes of Post-operative Opioid EXposure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents aged 12 to 17 years inclusive
- Scheduled for surgery with a high likelihood of requiring opioid pain medicine for at least 48 hours post-operatively
- Willing and able to provide informed assent
- Parent or legal guardian willing and able to provide informed consent
You will not qualify if you...
- Adolescents prescribed opioids in the past 2 years for chronic medical conditions
- Adolescents with chronic medical conditions needing ongoing opioid treatment such as sickle cell disease, arthritis, or cancer
- Adolescents without a caregiver willing to participate
- Adolescents who cannot read or speak English at a 4th-grade level
- Adolescents in custody of legal or child protective services or with pending legal actions preventing participation
- Adolescents who are pregnant or parenting
- Adolescents with a history or treatment for opioid use disorder
- Adolescents enrolled in other opioid or pain management intervention studies
- Parents or caregivers who cannot read or speak English or Spanish at a 4th-grade level
- Parents or caregivers who are currently incarcerated
- Parents or caregivers in physical or mental distress preventing participation as determined by staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants who undergo major surgery with planned post-operative opioid use are observed using data collected from electronic medical records and patient and parent reports to study opioid use disorder risk.
Data collected regularly via medical records and surveys during the year after surgery
Trial Site Locations
Total: 5 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
2
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Not Yet Recruiting
3
Boston Childrens Hopsital - Division of Addiction Medicine
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
5
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
Research Team
S
Sharon Levy, MD, MPH
J
Joesph Cravero, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here