Effects of Intraoperative Auditory Stimulation on Pain and Agitation on Awakening After Pediatric Adenotonsillectomy: A Randomized Clinical Trial.

Importance Severe pain on awakening (POA) and emergence delirium (ED) are common following pediatric adenotonsillectomy. Effective preventive interventions are lacking. Objective To determine the effects of intraoperative auditory stimulation on reduction of POA and ED after pediatric adenotonsillectomy. Design, setting, and participants Single-center, double-blinded, 4-armed, randomized clinical trial of children undergoing adenotonsillectomy from March 2018 to May 2019 at a tertiary care pediatric referral center. Interventions Children were randomized to 1 of the following groups: auditory stimulation with music, auditory stimulation with noise, ambient noise insulation with masking earplugs, and a control group receiving no intervention. Ear inserts were placed in the operating room once general anesthesia was administered. Stimulation parameters were based on the preoperative audiological evaluation and the appropriate fitting of the transduction system, including ambient noise level monitoring. Main outcomes and measures The primary outcome was POA levels measured on 10-point scales according to age-appropriate validated tools. The secondary outcome was ED levels assessed according to the Pediatric Anesthesia Emergence Delirium 20-point scale. Results A total of 104 consecutive healthy children (median [interquartile range] age at surgery, 5.0 [3.8-6.4] years) were included in the analysis. Music had a large effect size on POA (0.63; 98% CI, 0.43-0.84) and a medium effect size on ED (0.47; 98% CI, 0.21-0.75), while noise had a medium effect size on POA (0.47; 98% CI, 0.22-0.73) and a large effect size on ED (0.63; 98% CI, 0.44-0.85) compared with controls. The earplugs group showed a small effect size on POA and ED. Considering a clinically meaningful threshold of greater than 4 for POA and 10 or greater for ED at dichotomized analysis, a large effect size was achieved by music (1.39; odds ratio [OR], 0.08; 98% CI, 0.02-0.29; and 0.84; OR, 0.22; 98% CI, 0.06-0.75, respectively) and noise (0.97; OR, 0.17; 98% CI, 0.05-0.6; and 1.48; OR, 0.07; 98% CI, 0.02-0.26, respectively), while earplugs resulted in a small effect size. Conclusions and relevance In this randomized clinical trial, children undergoing adenotonsillectomy who received intraoperative auditory stimulation demonstrated a clinically meaningful decrease in POA and ED in the immediate postoperative period. Further research is needed to assess whether intraoperative auditory stimulation may decrease POA and ED in children undergoing other types of surgical procedures. Trial registration ClinicalTrials.gov Identifier: NCT04112979.