US multicentre randomised controlled trial protocol: Comparing Analgesic Regimen Effectiveness and Safety after surgery trial for Kids (CARES for Kids).

INTRODUCTION

Acute pain is an expected symptom for adolescents after outpatient surgery. In the USA, postoperative analgesic regimens frequently include prescription opioids. Increasing attention from clinicians, patients and other healthcare leaders has been directed toward non-opioid strategies, such as combining non-steroidal anti-inflammatory drugs (NSAIDs) plus acetaminophen, as potential first-line options for managing postoperative pain. However, the effectiveness and safety of home regimens that include versus exclude opioids for adolescents are unclear. The Comparing Analgesic Regimen Effectiveness and Safety after surgery for Kids study evaluates the effectiveness and safety of NSAIDs plus acetaminophen alone (NSAID regimen) versus NSAIDs and acetaminophen plus a low-dose opioid regimen (opioid regimen).

METHODS AND ANALYSIS: This study is a pragmatic, multicentre randomised controlled clinical trial recruiting 900 patients aged 12-20 years undergoing three common outpatient surgeries (tonsillectomy, laparoscopic cholecystectomy, knee arthroscopy) across four health systems. We will recruit patients prior to surgery and individuals will be randomised 1:1 with stratification to receive prescriptions for either the NSAID regimen or the opioid regimen. The primary effectiveness outcome is patient-reported pain intensity, while the primary safety outcome is adverse medication-related symptoms both assessed over the first 2 weeks after surgery. Secondary outcomes include quality of recovery, healthcare-related quality of life and rates of problematic substance use and chronic prescription opioid use, assessed up to 1 year after surgery.

ETHICS AND DISSEMINATION: The study incorporates stakeholder collaboration, including patient partners, surgeons, professional organisations., and health insurance payors, to ensure ethical conduct and relevance. This study is overseen by a single institutional review board with certificate of confidentiality. Findings will be disseminated through academic publications, conferences and community outreach to inform patients, parents, surgical teams and policymakers about optimal pain management strategies for adolescents after surgery.

TRIAL REGISTRATION NUMBER: NCT06671002.