Pain Mitigation in Pediatric Endoscopies Using Virtual Reality and Intranasal Midazolam

Introduction: Esophagogastroduodenoscopy (EGD) is a pain-related procedure with possible negative consequences in children. We aimed to prospectively compare three pain management approaches in deep sedated-EGD: Intravenous Midazolam (IVm), Virtual Reality (VR) +IVm, and Intranasal Midazolam (IN) +IVm, according to standard of care procedures. Materials and Methods: 72 children aged between 4 and 18 years old were randomly assigned to one of the groups (30IV, 30VR, and 12IN). Age, sex and baseline Children Emotional Management Scale (CEMS) were collected. Primary outcomes of the study were the self-reported (Visual Analog Scale, VAS) and observed pain (Face, Legs, Activity, Cry, Consolability Scale, FLACC). Secondary outcomes were a combined VAS+FLACC scale, pain rated by parents (Numerical Rating Scale, NRS), operator’s satisfaction, midazolam administered, presence of anterograde amnesia, time to discharge and side effects encountered. The Kruskal-Wallis and Fisher tests were used to test the effects of our interventions. Results: No significant differences in age, sex and CEMS were encountered. The VR group reported significantly lower pain than IV and IN groups (median VAS VR:0, IV:2, IN:5, p=0.0045; median FLACC VR:2, IV:4, IN:3.5, p=0.0204; median VAS+FLACC VR:3, IV:7, IN:9.5, p=0.0002, median NRS VR:0, IV:2.5, IN:3.5, p=0.0003). Amnesia covered EGD + venipuncture in IN group (75%), but only EGD in VR and IV groups (100%) (p<0.001). Side effects occurred at a rate of 83% in IN, 56% in VR, 33% in IV (p=0.0115). No other significant differences were observed. Conclusion: VR distraction reduces pain perception in children during EGD, without compromising the technical result of the procedure. This pilot study sets the stage for further investigations on the use of VR to improve pediatric patient’s care and outcomes.