Examining opioid use in adolescents after surgery

Adolescent Outcomes of Post-operative Opioid EXposure

This study looks at how surgery-related opioid use affects teenagers aged 12-17 and aims to find out what factors might lead to opioid use disorder after their surgery.

Quick facts

• Study type: Observational
• Enrollment: 20000 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Boston Children's Hospital (Academic / other)
• Locations: 5 sites (Aurora, Colorado and 4 other locations)
• Trial ID: NCT06350409 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the factors that contribute to the transition from medical opioid exposure to potential opioid use disorder (OUD) among adolescents aged 12-17 following major surgery. By collecting data from 10,000 adolescent-parent dyads, the study will utilize electronic surveys and electronic medical records to assess the risk factors associated with opioid use disorder in the year after surgery. The findings will help develop informed pain management protocols and screening tools to mitigate the risk of OUD in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-17 scheduled for major surgery with a high likelihood of requiring opioid analgesia post-operatively.

Not a fit: Patients who have been prescribed opioids for pain in the past two years will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies and reduced risk of opioid use disorder in adolescents post-surgery.

How similar studies have performed: Other studies have explored opioid use in similar populations, but this study's specific focus on post-operative outcomes and risk factors is relatively novel.

Eligibility criteria

Adolescent Inclusion Criteria

1. 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.
2. Adolescents willing and able to provide informed assent and have a parent/caregiver willing to provide informed consent.

Parent/Caregiver Inclusion Criteria

1. Parent or legal guardian of an eligible adolescent.
2. Parent or legal guardian willing and able to provide written informed consent.

Adolescent Exclusion Criteria

Adolescents meeting any of the following criteria will be excluded from study participation:

1. Adolescents who have been prescribed opioids in the past 2 years for pain due to a chronic medical condition.
2. Adolescents who have a current chronic medical condition that requires ongoing opioid pain management and treatment such as sickle cell disease, arthritis, or cancer.
3. Adolescents who do not have a caregiver who is willing to co-participate in the study.
4. Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff.
5. 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.
6. Adolescents who are currently in the custody of the Department of Children and Families or living with a foster family.
7. Adolescents who are currently pregnant or parenting.
8. 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.
9. Adolescents who are currently enrolled in an intervention study that aims to impact opioid prescription or pain management pre-, peri-, or post-operatively.

Parent/Caregiver Exclusion Criteria

Parents/Caregivers meeting any of the following criteria will be excluded from study participation:

1. Parents/Caregivers who cannot speak or read English or Spanish at a 4th grade level as determined by medical or research staff.
2. Parents/Caregivers that are currently incarcerated.
3. Parents/Caregivers that are in physical or mental distress that precludes study participation as determined by clinical or study staff.

Where this trial is running

Aurora, Colorado and 4 other locations

• Children's Hospital Colorado — Aurora, Colorado, United States (Not_yet_recruiting)
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (Not_yet_recruiting)
• Boston Childrens Hopsital - Division of Addiction Medicine — Boston, Massachusetts, United States (Recruiting)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Not_yet_recruiting)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Sharon Levy, MD, MPH

Conditions Opioid Use Disorder; Pain, Chronic; Adolescent Opioid Use; Post operative pain