Pediatric opioid use is a public health crisis. In children, prescription opioids are the primary source of non- medical abuse as well as opioid-associated hospitalizations and deaths. Early opioid use in childhood is a known gateway to adulthood dependence and substance abuse disorders. Despite years of research, opioids remain the most commonly prescribed pain medication for children with cancer. These children experience pain from the time of diagnosis into adulthood as survivors, primarily from the treatment for their cancer. The majority of pediatric cancer patients have persistent opioid use in the months following major surgery to cure or to treat their disease. More concerning, studies in childhood cancer survivors show that major surgery increases risk of new-onset and chronic opioid use. The high costs and lack of scalability of traditional distraction-based medical devices for managing pain, such as virtual reality headsets, limit their clinical impact and commercial potential. As cancer patients are often immunocompromised, risk from infectious disease transmission from sharing devices is an additional, possibly life-threatening, concern. Mobile augmented reality applications eliminate these limitations, representing a cost-effective, safe and commercially viable adjunctive tool for pain management in critically ill children. Our goal is to reduce long-term opioid use in children with cancer undergoing major surgery by distracting them from their pain with a scavenger hunt-style mobile AR game while they are recovering in the hospital. To achieve this goal, we have collaborated with pediatric oncologists, anesthesiologists and pain specialists at the MD Anderson Cancer Center and the Baylor College of Medicine (Texas Childrens Hospital). In Phase I, we will demonstrate the feasibility of investigating the ARISE (Augmented Reality Incorporating Spatial Enhancement) game for reducing opioid consumption in the inpatient postoperative wards. In Phase II, we will evaluate the efficacy of the game to reduce immediate and long-term postoperative opioid use in children with cancer undergoing major treatment-related surgery in a multi-site randomized controlled clinical trial (AURORA trial: Augmented Reality for Opioid Reduction in Childhood Cancer). To our knowledge, this is the first RCT to investigate mobile augmented reality for opioid reduction in pediatric cancer patients or for postoperative opioid reduction in any pediatric population. As the majority of children with cancer are expected to survive long-term, the benefits of reducing and preventing chronic opioid use in this high-risk, refractory pain population will last over the lifetime of a child.
Public Health Relevance Statement: PROJECT NARRATIVE In this STTR, ALTality, Inc. (otherwise known as SpellBound) will assess the feasibility and efficacy of an inpatient augmented reality game (ARISE: Augmented Reality Incorporating Spatial Enhancement) to reduce acute and chronic opioid use in children with cancer following major surgery in collaboration with pediatric oncologists, anesthesiologists and pain specialists at the MD Anderson Cancer Center and the Texas Childrens Hospital. If successful, the ARISE AR game will be a cost-effective, safe and commercially viable adjunctive tool for pain management urgently needed to prevent long-term opioid use, abuse and dependency in a critically ill, high-risk pediatric population.
Project Terms: 3-Dimensional; academic review; Acute; Adult; Analgesics; Augmented Reality; base; Beds; Cancer Center; Cancer Patient; Caregivers; Cessation of life; Child; Childhood; childhood cancer survivor; Chronic; Clinical; clinical pain; Clinical Trials; cognitive modulation of pain; Collaborations; Collection; college; commercial application; Control Groups; cost; cost effective; Critical Illness; Critically ill children; Data; Data Analyses; Dependence; design; Device Approval; Devices; Diagnosis; Disease; disease transmission; distraction; Dose; Effectiveness; experience; Family; Feasibility Studies; Feedback; Future; Goals; Grant; handheld mobile device; health care settings; high risk; high risk population; Hospitalization; Hospitals; Human Resources; Hyperalgesia; Immunocompromised Host; Inpatients; Institutional Review Boards; Intractable Pain; Journals; Legal patent; Life; Malignant Childhood Neoplasm; Malignant Neoplasms; Manuscripts; Medical Device; Medicine; mobile application; morphine equivalent; Movement; non-opioid analgesic; nonmedical use; Operative Surgical Procedures; Opiate Addiction; Opioid; opioid abuse prevention; opioid use; Outcome; Outpatients; Pain; Pain management; pain reduction; patient population; Patients; Pediatric cohort; Pediatric Hospitals; Pediatric Oncologist; Pediatric Oncology; pediatric patients; Peer Review; Perioperative; Persons; Pharmaceutical Preparations; Phase; phase 2 study; Phase II Clinical Trials; Population; Postoperative Pain; Postoperative Period; prescription opioid; prevent; Procedures; Protocols documentation; Public Health; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Reporting; Research; Risk; satisfaction; Sickle Cell Anemia; Site; Small Business Technology Transfer Research; Source; Specialist; Substance abuse problem; Surgical Oncology; Surveys; Survival Rate; Survivors; Testing; Texas; Time; tool; Toxic effect; Training; Trauma; United States National Institutes of Health; usability; virtual reality headset; ward
