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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
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