Teens and opioids postsurgery (TOPS): protocol for a prospective observational study describing associations between sleep deficiency and opioid use following outpatient surgery in adolescents.

INTRODUCTION

The opioid crisis is a significant burden on adolescent public health in the USA. Medical use of prescription opioids is a pathway via which adolescents transition to opioid misuse, opioid use disorder and overdose. More than half of all opioids prescribed to adolescents are for pain management following surgery. Yet, little is known about the critical period following surgery during which adolescents initiate opioid misuse or the modifiable mechanisms (such as sleep deficiency) contributing to this process. This prospective observational study will broaden our knowledge by examining associations between sleep deficiency and opioid use and misuse following surgery. We will also examine behavioural, psychological, family and social factors linking sleep deficiency with opioid use and misuse.

METHODS AND ANALYSIS

Adolescents (10-19 years) undergoing outpatient orthopaedic surgery, along with one parent, will be recruited from two paediatric hospitals, for a sample of 400 dyads. Adolescents will be assessed at six timepoints. Before surgery, participants will undergo comprehensive multimodal sleep assessments (sleep surveys and actigraphy). Participants will also report on previous substance use, pain intensity and psychosocial, family and social factors. Adolescents will then be closely monitored over the first 14 days following surgery using ecological momentary assessment methods to capture real-time, naturalistic, daily data on sleep, opioid use, pain and psychological factors (including mood, affect and subjective response to opioid use). Opioid use (total number of doses and duration) will be measured with an innovative electronic medication monitoring device following surgery. Follow-up assessments at 3 months, 6 months, 12 months and 24 months will track the development of opioid misuse over time. Our primary outcomes include opioid use during the immediate 14 days following surgery and the presence of opioid misuse at 24 months after surgery. Multilevel mediation models will determine associations between predictor variables and acute postsurgical opioid use. We will apply modern machine learning algorithms to develop and validate models predicting adolescent prescription opioid misuse at 24 months from surgery.

ETHICS AND DISSEMINATION

This study was approved by Advarra's Center for Institutional Review Board Intelligence (CIRBI) (Protocol 00072049), which serves as the single IRB of record for this multisite study.