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

Not Applicable

Completed

• Conditions: Recurrent tonsillitis; Sleep disordered breathing; Respiratory - Sleep apnoea; Infection - Other infectious diseases; Surgery - Other surgery

• Registration Number: ACTRN12622000327785
• Lead Sponsor: Jemma Porrett

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-22
• Study Completion: 2023-11-27
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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, ]; 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, ]