Every day, thousands of adolescents and young adults undergo outpatient surgery and return home to recover. Pain after surgery is very common and one of the top concerns of patients, their families and clinicians who care for them. However, the best way to treat it is not clear.
Surgeons usually prescribe medicine in one of two ways to relieve pain after surgery. One approach is to use a nonsteroidal anti-inflammatory drug (NSAID) with acetaminophen. Another approach is to take low-dose opioid medications along with an NSAID and acetaminophen. Both approaches commonly help to relieve pain but may also lead to side effects. Currently, it is not clear which approach is the best and safest way to help adolescents and young adults recover after surgery.
This study, CARES for Kids: Comparing Analgesic Regimen Effectiveness and Safety for Kids after surgery, will compare how well the NSAID approach and the low-dose opioid approach help patients recover at home after surgery. The objective is to identify the approach that works the best and is the safest for adolescents and young adults to take. The study’s aims are to compare:
- How well the NSAID and low-dose opioid approaches reduce pain after surgery
- Short-term harms of the two approaches
- Impact of two approaches on other outcomes important to patients and their families after surgery
Findings from this study will help adolescents and young adults, their families and clinicians who care for them make better decisions about how to manage pain after surgery in the best and safest way. The study will enroll 900 adolescents and young adults aged 12-20 years who have surgery at four locations across the United States. Researchers will recruit patients for the study by speaking to them in the time between when they sign up for surgery and the day of their procedure.
This study will examine three types of procedures: tonsil removal, gallbladder removal, and knee scope. The research team will assign patients by chance on the day of surgery for their surgical team to prescribe either the NSAID approach or the low-dose opioid approach for their discharge medications. Patients will know which approach is prescribed. Patients will be asked to complete surveys up to 12 months after surgery. Researchers will ask questions using surveys that can be answered on a mobile device or by a telephone call. Patients who do not have a mobile device will be provided with one to use during the study.
Stakeholders and patient partners helped choose the focus of the study and the topics of the questions to ask. For the primary outcome, researchers will measure pain reported by patients after surgery up to the first 14 days after surgery. They will also measure side effects reported by patients as the main safety outcome every day for the first 14 days after surgery and then at one month.
Participants will report other important outcomes after surgery, including recovery at two days and sleep at one month. Impact of pain on function will be measured at one and two weeks, and every three months up to one year. Opioid misuse will be measured every three months up to one year. Quality of life, substance use and new prolonged opioid use will also be measured up to one year. Researchers will review the medical record for surgical complications at one month, six months and one year.
The study team values the input of different types of stakeholders to help guide the design and conduct of the study and to help share study results. The study will benefit from a Stakeholder Advisory Board with members consisting of adolescent and young adult patients; their family members; and other stakeholders from community groups, payers, and professional and research organizations. Study results will fill key gaps in what is known about how effective and how safe pain medications are for adolescents and young adults after surgery.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.