Adolescent Outcomes of Post-operative Opioid EXposure
APEX
3 other identifiers
observational
20,000
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedStudy Start
First participant enrolled
November 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
March 18, 2026
March 1, 2026
3.2 years
April 1, 2024
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery.
The patient self-report an average pain score of more than 3/10 in the last 7 days on the Brief Pain Inventory (BPI) at 3 or more months postoperatively.
12 months
Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery.
Any adolescent self-report or parent report of opioid medication use more than 3 or more months postoperatively.
12 months
Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery.
Any adolescent self-report or parent report of use of opioid medication that is \> than prescribed, or more frequently than prescribed, or not prescribed to the adolescent.
12 monhts
Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery.
Adolescent self-report of rate of increase of substance use frequency greater than the 75th percentile of an age- and sex-matched cohort compared to nationally representative data
12 month
Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery.
Adolescent self-report of post-surgical trauma and stress as measured by \>11 on the Child PTSD Symptom Scale (CPSS) 3 or more months postoperatively.
12 months
Eligibility Criteria
This study aims to recruit a convenience sample of approximately 10,000 dyads of adolescent (12-17 years, inclusive) patients and one parent (Total N=20,000). Adolescent participants will be undergoing scheduled surgeries 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. Exemplar surgeries at BCH and CCHMC sites include spinal fusion surgery, Nuss procedure, and anterior cruciate ligament reconstruction. Both inpatient and outpatient surgical procedures will be considered. All adolescent participants will be aged 12-17 at the time of enrollment and are children as defined by the NIH Policy on I
You may qualify if:
- 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.
You may not qualify if:
- Adolescents meeting any of the following criteria will be excluded from study participation:
- Adolescents who have been prescribed opioids in the past 2 years for pain due to a chronic medical condition.
- Adolescents who have a current chronic medical condition that requires ongoing opioid pain management and treatment such as sickle cell disease, arthritis, or cancer.
- Adolescents who do not have a caregiver who is willing to co-participate in the study.
- Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff.
- Adolescents who are currently in the custody of the Department of Youth Services, jail/prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
- Adolescents who are currently in the custody of the Department of Children and Families or living with a foster family.
- Adolescents who are currently pregnant or parenting.
- Adolescents that self or parent report of ever having been diagnosed with opioid use disorder, or prescribed buprenorphine, methadone, or naltrexone to treat opioid use disorder.
- Adolescents who are currently enrolled in an intervention study that aims to impact opioid prescription or pain management pre-, peri-, or post-operatively.
- Parents/Caregivers meeting any of the following criteria will be excluded from study participation:
- Parents/Caregivers who cannot speak or read English or Spanish at a 4th grade level as determined by medical or research staff.
- Parents/Caregivers that are currently incarcerated.
- Parents/Caregivers that are in physical or mental distress that precludes study participation as determined by clinical or study staff.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sharon Levylead
- National Institute on Drug Abuse (NIDA)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (5)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Boston Childrens Hopsital - Division of Addiction Medicine
Boston, Massachusetts, 02115, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief, Division of Addiction Medicine
Study Record Dates
First Submitted
April 1, 2024
First Posted
April 5, 2024
Study Start
November 12, 2024
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
March 18, 2026
Record last verified: 2026-03