BiZact vs Bipolar Pediatric Tonsillectomy: A Randomized Controlled Trial

Abstract

Introduction

Tonsillectomy is a commonly performed and relatively safe procedure, however it does have side effects and complications. Post-operative pain is the most common side effect and bleeding is the most significant complication. There is currently no evidence-based surgery-specification guidelines in the United States, United Kingdom and Australia describing the optimal technique for tonsillectomies. ‘Cold-steel’ dissection remains the most common technique worldwide while bipolar tonsillectomy is the most commonly used technique at the Queensland Children's Hospital. The BiZact device, with advanced bipolar energy allowing for continuous measurement of tissue impedance, was approved for use in Australia in 2016. This study aimed to determine postoperative morbidity in pediatric patients undergoing BiZact tonsillectomy compared to bipolar tonsillectomy.

Methods

A prospective, double-blinded, randomized control trial was conducted at the Queensland Children's Hospital. A total of 100 children, aged 3-17 years, with sleep disordered breathing or recurrent tonsillitis requiring tonsillectomy were included. Participants were randomized (1:1) to undergo BiZact or bipolar tonsillectomy. The primary objective was to assess post-operative pain using the FACES® Pain Rating Scale Revised and the Numeric Pain Rating Scale. The use of oxycodone and the return to normal diet and activities was also measured. Surgical timing, time taken to reach haemostasias, and post-operative complications were compared.

Results

This project's results are currently pending.

Conclusion

Guidelines describing the optimal technique for tonsillectomies need to be developed on evidence-based outcomes. This study will determine if BiZact is more effective than Bipolar tonsillectomy at reducing post-operative pain and bleeding in the pediatric population.