Adolescent Outcomes of Post-operative Opioid EXposure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-17
SponsorSharon Levy
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months2
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.
Time frame
12 months3
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.
Time frame
12 monhts4
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
Time frame
12 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sharon Levy
Lead sponsor
Boston Children's Hospital
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov