# Clinical Trials Network: Admin Supplement: Post-Surgical Adolescent Outcomes

> **NIH NIH UG1** · YALE UNIVERSITY · 2023 · $2,549,046

## Abstract

PROJECT SUMMARY/ABSTRACT
Opioid misuse and overdose remain a major public health crisis in the United States, especially for youth.1,2 In
2022, more than 110,000 people died from opioid overdoses.3 While the rate of intentional drug overdoses fell
among middle-aged adults from 2015-2019, it rose among youth aged 15-24.2 Rates of opioid overdose
increased for all age groups in 2020 and 2021, with the largest increases among adolescents in both years.4
Approximately 4 million children and adolescents (age 0-17) undergo surgical procedures every year in the
United States,5 which present a first exposure to opioids for many and may become a driver of future opioid
use disorders (OUD) in this vulnerable age group.6–9
This project aims to confront an important aspect of the national opioid crisis by providing greater insight into
OUD risk after initial opioid exposure in the surgical setting during adolescence. The proposed study will lay
the groundwork for the development of better and safer pain management strategies for adolescents
undergoing major surgery and will inform guidelines for opioid prescribing to adolescents by establishing a
multicenter prospective, cohort. We will investigate the impacts of individual sociodemographic and clinical
characteristics, intra-operative factors, and postoperative surgical course on the development of markers of
elevated risk for OUD. Outcomes of interest include prolonged opioid use after surgery and postoperative non-
medical use of prescription opioids (NMUPO) which are risk factors for subsequent OUD in this vulnerable
adolescent population.
We will recruit a diverse sample of 10,000 adolescents (aged 12 to 17 years) undergoing a painful surgical
procedure. We will survey patients and parents preoperatively and at 5 time points up to 12 months post-
operatively to understand patient experiences of pain and related patient reported outcomes. Survey data will
be combined with structured clinical pre- intra- and post-operative data abstracted from the electronic medical
record to characterize the inter-relationships among patient experiences, behaviors, and clinical course.
Our findings could revolutionize post-operative pain care for this vulnerable population. Results will inform
screening and assessment of OUD risk prior to opioid prescribing, strategies for reducing OUD risks for those
undergoing painful procedures, and recommendations for monitoring of patients being treated for pain.
Additionally, the project enables the establishment of an infrastructure among pediatric surgical centers that
can be used for future projects to further evaluate best practices for securing favorable post-operative
outcomes for youth.

## Key facts

- **NIH application ID:** 10801999
- **Project number:** 3UG1DA015831-22S4
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Gail D'Onofrio
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $2,549,046
- **Award type:** 3
- **Project period:** 2002-09-30 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10801999

## Citation

> US National Institutes of Health, RePORTER application 10801999, Clinical Trials Network: Admin Supplement: Post-Surgical Adolescent Outcomes (3UG1DA015831-22S4). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10801999. Licensed CC0.

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