Virtual reality paired with nitrous oxide for procedural pain in children: a randomized controlled trial.

Objective: To assess the efficacy and clinical implementation of virtual reality (VR) paired with nitrous oxide for procedural pain management during botulinum toxin (BoNT) injections in children with developmental disabilities. Methods: A randomized, crossover study was conducted with 31 children with developmental disabilities receiving BoNT injections with nitrous oxide (median age = 10 years, range = 5-17 years; 16 males). Child life specialists facilitated VR during one BoNT appointment and standard of care distraction (eg, music, tablet) at another. Primary outcomes included pain experience assessed using the Faces Pain Scale-Revised, anxiety, and nitrous oxide concentrations. Secondary outcomes assessed clinical implementation by side effects, preferences, and acceptability. Results: Children, parents, and child life specialists reported significantly lower pain scores, and nitrous oxide concentrations were reduced in the VR condition compared with standard of care. Virtual reality paired with nitrous oxide was used throughout the procedure for most children (n = 23; 74.2%). Eight children discontinued VR during the procedure (preference [n = 3], mild side effects [n = 5]). The procedure duration did not differ between conditions, and parents reported greater satisfaction with their experience when VR was used. Conclusion: On average, when VR was used, pain levels were lower while also using lower nitrous oxide concentrations. Implementation of VR into the clinical context, paired with nitrous oxide, appeared beneficial and clinically efficient. Virtual reality in combination with nitrous oxide may provide synergistic effects for procedural sedation resulting in improved patient experiences. Further research is warranted to explore potential effect modifiers for a personalized medicine approach.