BiZactTM versus bipolar paediatric tonsillectomy: A double-blinded randomised control trial.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: 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. CONDITION: Infection ‐ Other infectious diseases Recurrent tonsillitis ;Sleep disordered breathing ; ; Recurrent tonsillitis ; ; ; Sleep disordered breathing Respiratory ‐ Sleep apnoea Surgery ‐ Other surgery PRIMARY OUTCOME: The primary objective is to assess the severity of post‐operative pain in paediatric population following tonsillectomy using the Numeric Pain Rating Scale. [This will be performed at 6 hours post‐operatively as well as days 1,3, 5, 7 and 14 days post‐operatively, ] The primary objective is to assess the severity of post‐operative pain in paediatric population following tonsillectomy using the FACES® Pain Rating Scale Revised[This will be performed at 6 hours post‐operatively as well as days 1,3, 5, 7 and 14 days post‐operatively, ] SECONDARY OUTCOME: Day of cessation of oxycodone ‐ recorded by patient or carer and reported to surgeon blinded to technique at time of post‐operative follow up Day 28 +/‐7 . [Up to day 14 post‐operatively ] Delayed discharge ‐ documented on data collection sheet throughout inpatient stay by member that is blinded to the surgical technique. [Day 1‐2 post‐operatively ] Hospital readmission recorded by team member blinded to technique at time of post‐operative follow up Day 28 +/‐7 . [Up to day 14 post‐operatively ] Oxycodone use ‐ ‐ recorded by patient or carer and reported to surgeon blinded to technique at time of post‐operative follow up Day 28 +/‐7 . [Up to day 14 post‐operatively ] Post‐tonsillectomy bleeding ‐ recorded by team member blinded to technique at time of post‐operative follow up Day 28 +/‐7 . [Up to day 14 post‐operatively ] Return to normal activities ‐ recorded by patient or carer and reported to surgeon blinded to technique at time of post‐operative follow up Day 28 +/‐7 . [Up to day 14 post‐operatively ] Return to normal diet ‐ recorded by patient or carer and reported to surgeon blinded to technique at time of post‐operative follow up Day 28 +/‐7 . [Up to day 14 post‐operatively ] Time for conduction of tonsillectomy‐ The surgical time will be assessed for removal of left and right tonsil defined as time from incision of superior pillar to placement of tonsil on the operative table. Collected using data collection sheet. [Intra‐operatively ] INCLUSION CRITERIA: Assigned for tonsillectomy +/‐ adenoidectomy +/‐ grommets due to recurrent tonsillitis or sleep disordered breathing Available for ongoing follow up and review
Epistemonikos ID: 18b41fee7c1b5857ca315fdc61ef0f068f17dbf1
First added on: Aug 25, 2024