A “gold standard” study to answer the question for adolescents and young adults undergoing common surgeries.
LOS ANGELES (November 28, 2023)—Thousands of adolescents and young adults have outpatient surgery every day and are sent home with pain medication. Although the need for medication is clear, the best way to treat the pain is not. A new study led by investigators at the University of Michigan and Children’s Hospital Los Angeles will compare two treatment regimens—one that uses a regimen of non-opioid medication and another that adds a low-dose opioid—to determine the safest and most effective way to treat pain in adolescents and young adults recovering from common outpatient surgeries.
In the past, opioids were commonly prescribed to treat pain following surgery. However, the opioid epidemic has caused families and physicians to be reluctant about exposing young people to these medications due to side effects and the possibility of abuse. This has led many healthcare providers to use nonsteroidal anti-inflammatory drugs (NSAIDs) plus acetaminophen without prescribing opioids. But the question remains: Do these medications adequately relieve pain?
“This study will provide the information that I need to be able to counsel families,” says Lorraine Kelley-Quon, MD, a pediatric surgeon at Children’s Hospital Los Angeles and co-principal investigator of the study. “We need to define the right balance of medications to effectively minimize pain while not introducing unwanted side effects. This study will provide that missing information.”
The CARES for Kids study (Comparing Analgesic Regimen Effectiveness and Safety After Surgery for Kids) will be the first prospective, randomized, controlled trial—considered the gold standard—comparing opioid and non-opioid pain medication following common surgical procedures in adolescents and young adults. The Patient-Centered Outcomes Research Institute (PCORI) has approved nearly $7 million of funding to support this study, which aims to generate this research-based evidence.
“Appropriate pain relief impacts many people—the patient, their family, the surgeon and the patient’s physician,” says Mark Bicket, MD, PhD, an anesthesiologist at the University of Michigan and principal investigator of the study. “All these people come from different perspectives but have the same objective—the safety and comfort of the patient. This study incorporates these varied viewpoints by having an advisory board involved from the earliest days of study design until the study conclusion.” The advisory board includes patients, caregivers, pediatric medical and surgical associations, payers and community organizations.
The study will enroll 900 adolescents and young adults between 12 to 20 years of age who are undergoing tonsil removal, gallbladder removal or arthroscopic knee surgery. Participating patients will be randomly assigned on the day of surgery to receive either an NSAID and acetaminophen alone or a regimen that also includes a low-dose opioid. Subsequently they will be surveyed on a mobile device or by a phone call up to one year after surgery to answer questions about short- and long-term pain, insomnia, medication side effects like constipation and prolonged opioid use or misuse.
Patients will be enrolled at these four study sites:
- Children’s Hospital Los Angeles (CA)
- Nationwide Children’s Hospital (OH)
- Stanford Medicine Children’s Health (CA)
- Michigan Medicine (MI)
“We are grateful to PCORI for taking a leadership role in funding multiple trials to develop research-based evidence about the effectiveness of using pain medication in adults,” says Dr. Kelley-Quon. “But since it isn’t possible to extrapolate information gained from an adult study to a pediatric population, this is a truly unique study—done in adolescents and young adults—and will impact millions of families each year.”
Funding for this study has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.
About Children’s Hospital Los Angeles
Founded in 1901, Children’s Hospital Los Angeles is at the forefront of pediatric medicine and is the largest provider of hospital care for children in California. Children’s Hospital is home to renowned experts who work together across disciplines to deliver inclusive and compassionate care, and drive advances that set pediatric standards across the nation and around the globe. Children’s Hospital Los Angeles delivers a level of care that is among the best in the world for a truly diverse population of children. The Hospital is consistently ranked in the top 10 in the nation on U.S. News & World Report’s Honor Roll of Best Children’s Hospitals, including No. 1 in California and No. 1 in the Pacific U.S. region. Children’s Hospital Los Angeles embraces the hospital’s mission to create hope and build healthier futures. Children’s Hospital Los Angeles is among the top 10 children’s hospitals for National Institutes of Health funding. The Saban Research Institute of Children's Hospital Los Angeles supports the full continuum of research, allowing physicians and scientists to translate discoveries into treatments and bring answers to families faster. The pediatric academic medical center also is home to one of the largest training programs for pediatricians in the United States. And the hospital’s commitment to building strong communities is evident in CHLA’s efforts to fight food insecurity, enhance health education and literacy, and introduce more people to careers in health care. To learn more, follow CHLA on Facebook, Instagram, LinkedIn, YouTube and X, formerly known as Twitter, and visit CHLA.org/blog.