None listed
Conditions
Brief summary
Tonsillectomy, with or without adenoidectomy, is one of the most commonly performed otolaryngological procedures, occurring in 75 per 10,000 Australian children. The evolution of different techniques and devices throughout the years, along with the contradictory outcome measures, has resulted in there being no international consensus regarding the optimal technique for tonsillectomies and the decision on which technique is used often comes down to the surgeon’s experience and the perceived benefits of the different techniques. In this study, we aim to perform a prospective, randomized, blinded study to compare post-operative pain in patients undergoing BiZact tonsillectomy compared to bipolar tonsillectomy. We hypothesis less pain will be experienced post-operatively in patients undergoing BiZact tonsillectomy.
Interventions
Bizact Bilateral tonsillectomy, performed by an ENT surgeon or training surgeon, performed with an approximate duration of <30minutes. Monitoring of adherence of intervention by intermittent audit of operation reports.
Sponsors
Jemma Porrett
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Assigned for tonsillectomy +/- adenoidectomy +/- grommets due to recurrent tonsillitis or sleep disordered breathing Available for ongoing follow up and review
Exclusion criteria
- History of peritonsillar abscess - Coagulation disorder - Suspicion of malignancy - Single sided tonsillectomy - Craniofacial disorders - Down Syndrome - Cerebral palsy or complex neurological condition
Outcome results
None listed