Assessment of 14-Day Outcomes With the Peak® Surgery System Versus the Traditional Electrocautery Method in Children Ages 3 to 18 Years Undergoing Tonsillectomy With Adenoidectomy for Sleep Disordered Breathing

Detailed Summary

Given the large numbers of children who undergo tonsillectomy (by the time a child is 15 years old, 13% of his/her peers will have had a tonsillectomy), the significant morbidity, and direct and indirect costs associated with absences for child from school or parent from work or other responsibilities, it is vitally important to identify surgical techniques which will minimize pain and serious negative outcomes. This study aims to compare a new surgical technique, PEAK® Surgery System, with electrocautery, one of the most commonly used methods for tonsillectomy with or without adenoidectomy in children 3 to 6 years old with a diagnosis of sleep-disordered breathing. In this project, the investigator will evaluate intra-operative outcomes including, surgery time and bleeding rates, and post-operative pain scores, bleeding rates, time to resumption of normal diet and activity, analgesic type and use, and frequency of emergent visits over 14 days following surgery. The hypothesis is that there is no difference in outcomes between the traditional extracapsular electrocautery dissection method of tonsillectomy versus the newly introduced Peak® Surgery System. The long-term goal is to minimize pain and risk of bleeding and shorten the time to resumption of normal eating and activities in children undergoing tonsillectomy.

Study Details

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Interventions