Reducing distress for children during invasive procedures: randomized clinical trial of effectiveness of the PediSedate®

Background: Procedural pain control remains problematic for young children, especially during anxiety‐causing procedures for which children should not be deeply sedated. The PediSedate^® was designed to address this problem by delivering nitrous oxide in oxygen through a simple nosepiece, combined with an interactive video component, so that children can use attention and distraction with drug delivery. Objectives: We conducted a randomized clinical trial to evaluate the effectiveness of the PediSedate^® for reducing children’s behavioral distress in comparison with standard care in the emergency department. Secondary objectives were to assess children’s acceptance, cooperation, and pain. Methods: Thirty‐six children, aged 3–9 years old, who required invasive procedures associated with high levels of anxiety and low levels of pain such as sutures, IVs, and lumbar punctures were randomized to receive either the standard care or the PediSedate^®. The primary outcome was children’s distress (observational scale of behavioral distress) that was monitored before and during the procedure. Results: Children randomized to the PediSedate^® group had significantly less distress during invasive procedures (mean = 1.8, sd = 3.2) than children receiving standard care (mean = 9.3, sd = 5.6; anova , P < 0.0001). Also, children in the PediSedate^® group were more cooperative [χ²(1) = 22.05, P < 0.0001] and fewer children reported pain [χ²(1) = 14.45, P < 0.001]. Conclusions: Previous studies have demonstrated the effectiveness of nitrous oxide sedation alone for minimizing pain and distress during invasive procedures. We have found that delivering nitrous oxide sedation via a system combined with an interactive video component is also effective. Further studies should determine which factors are dominant and determine the specific failure rate for this delivery system in comparison with other systems.