Adolescent Outcomes of Post-operative Opioid EXposure

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Sharon Levy
Study ID
NCT06350409
Status
Recruiting
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Conditions

  • Opioid Use Disorder
  • Pain, Chronic

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
20,000 participants (estimated)

Primary Outcome Measure

Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery. [ Time Frame: 12 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Tessa Mandler, MD
[email protected]
800-624-6553
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701
Allison Fernandez, MD
[email protected]
800-456-4543
Boston Childrens Hopsital - Division of Addiction MedicineBostonMassachusetts02115
Melissa Brogna, MSW
[email protected]
857-218-4311
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Vydia Chidambaran, MD
[email protected]
(513) 636-4408
Charlotte Walter, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Tori Sutherland, MD
[email protected]
215-590-1000

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COJohns Hopkins All Children's Hospital· St. Petersburg, FLBoston Childrens Hopsital - Division of Addiction Medicine· Boston, MACincinnati Children's Hospital Medical Center· Cincinnati, OHChildren's Hospital of Philadelphia· Philadelphia, PA

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