BiZact versus bipolar paediatric tonsillectomy: a randomised controlled trial

Background: Tonsillectomy is one of the most commonly performed otolaryngological procedures that involve the use of various surgical devices. The BiZact^TM tonsillectomy device (Medtronic, Minneapolis, MN, USA) (hereafter referred to as BiZact) utilises advanced bipolar energy to reduce lateral thermal spread, which has the potential to reduce post-operative morbidity. To date, there is limited data available for comparing post-operative pain, recovery and complications between BiZact and bipolar diathermy in paediatric patients. This study aimed to investigate the impact of BiZact versus bipolar diathermy extracapsular tonsillectomy on post-operative outcomes in an Australian paediatric population.

Methods: A prospective, single-centre, randomised controlled trial was conducted at the Queensland Children's Hospital. A total of 100 patients aged 3–17 years undergoing tonsillectomy were enrolled and randomised to BiZact or bipolar diathermy tonsillectomy at a 1:1 ratio. Post-operative pain was evaluated using the Faces Pain Scale–Revised and the Numeric Pain Rating Scale at 6 hours and days 1, 3, 5, 7 and 14 post-operatively. The secondary outcomes included surgical timing, post-operative complications, time to return to normal diet and activities as well as time to oxycodone cessation.

Results: Post-operative pain scores were similar between groups at 6 hours and on post-operative days (POD) 1, 3, 5 and 7. A statistically significant difference was observed on POD 14, with lower pain scores in the BiZact group {median [interquartile range]: 0 [0–0] vs. 0 [0–2], P=0.01}, although pain scores were low in both groups. Time to return to normal activity was similar between groups [mean 8.97 vs. 8.77 days; mean difference 0.20 days, 95% confidence interval (CI): −1.24 to 1.64; P=0.78], as was time to return to normal diet (8.68 vs. 8.93 days; mean difference −0.25 days, 95% CI: −1.72 to 1.22; P=0.73) and opioid cessation (7.00 vs. 6.94 days; mean difference 0.06 days, 95% CI: −0.98 to 1.10; P=0.90). Delayed discharge occurred in 3/50 (6%) patients in the bipolar cohort and 0/50 patients in the BiZact cohort. A single primary haemorrhage occurred in the bipolar cohort and was managed conservatively. Post-operative secondary haemorrhage occurred in 3/48 (6%) patients in the BiZact group and 6/48 (12%) in the bipolar group, corresponding to a risk difference of −6.3% (95% CI: −17.9% to 5.4%; P=0.49). One patient in the bipolar cohort required a return to theatre for the management of secondary post-tonsillectomy bleeding.

Conclusions: This randomised controlled trial found comparable early post-operative pain scores between BiZact and bipolar diathermy extracapsular tonsillectomy. Fewer delayed discharge events were observed in the BiZact cohort, with lower POD 14 pain scores; however, these findings should be interpreted cautiously given the low event rate, low absolute late pain scores and limited sample size. Larger multicentre studies are needed to further assess complications and confirm the clinical relevance of differences in overall recovery.

Trial Registration: Australian New Zealand Clinical Trials Registry; ANZCTR; registration ID: ACTRN12622000327785.