A Pilot Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (The GAMING-ON Study).
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INTRODUCTION: Pediatric musculoskeletal and cancer surgeries often lead to significant postoperative pain. Augmented reality (AR), a non-pharmacological approach to pain modulation, has been insufficiently studied for its potential role in reducing opioid use following major surgery in children. METHODS: In this pilot trial, we randomly assigned pediatric patients undergoing major surgery, in a 1:1 ratio, to an AR versus non-AR scavenging game postoperatively. Randomization was stratified according to the study site. The primary endpoint was the rate of persistent opioid use measured at 90 days after hospital discharge. Secondary endpoints included pain intensity, opioid use, inpatient ambulation or "out of bed", movement, length of stay, and adverse events. We considered the trial a success if the rate of opioid use at 90 days postoperatively was significantly lower in the AR arm than in the non-AR arm. RESULTS: A total of 66 patients underwent randomization (n = 33 in each arm). The median age of each group was 12 years old. There were more females (72.7%) in the AR group than in the non-AR group (48.5%). Most patients (80%) had undergone oncological surgeries. The primary endpoint was met in over 95% of the patients. The overall rate of opioid use was low in both groups of patients (AR: 6.1% and non-AR: 9.7%) and did not reach statistical significance (p = 0.667). There were no statistically significant differences in secondary outcomes. CONCLUSION: In conclusion, this pilot study does not support the use of AR aimed at reducing the rate of persistent opioid use following pediatric surgery.