Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000327785p
Ethics application status
Submitted, not yet approved
Date submitted
30/12/2021
Date registered
22/02/2022
Date last updated
22/02/2022
Date data sharing statement initially provided
22/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
BiZactTM versus bipolar paediatric tonsillectomy: A double-blinded randomised control trial.
Scientific title
The effect of using BiZactTM versus bipolar diathermy on post-operative pain in paediatric tonsillectomy: A double-blinded randomised control trial
Secondary ID [1] 306020 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent tonsillitis

324654 0
Sleep disordered breathing 325012 0
Condition category
Condition code
Respiratory 322106 322106 0 0
Sleep apnoea
Infection 322447 322447 0 0
Other infectious diseases
Surgery 322448 322448 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322421 0
Treatment: Devices
Intervention code [2] 322680 0
Treatment: Surgery
Comparator / control treatment
Bipolar diathermy 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.
Control group
Active

Outcomes
Primary outcome [1] 329868 0
The primary objective is to assess the severity of post-operative pain in paediatric population following tonsillectomy using the FACES® Pain Rating Scale Revised
Timepoint [1] 329868 0
This will be performed at 6 hours post-operatively as well as days 1,3, 5, 7 and 14 days post-operatively,
Primary outcome [2] 330225 0
The primary objective is to assess the severity of post-operative pain in paediatric population following tonsillectomy using the Numeric Pain Rating Scale.
Timepoint [2] 330225 0
This will be performed at 6 hours post-operatively as well as days 1,3, 5, 7 and 14 days post-operatively,
Secondary outcome [1] 404101 0
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.
Timepoint [1] 404101 0
Intra-operatively
Secondary outcome [2] 405356 0
Delayed discharge - documented on data collection sheet throughout inpatient stay by member that is blinded to the surgical technique.
Timepoint [2] 405356 0
Day 1-2 post-operatively
Secondary outcome [3] 405357 0
Post-tonsillectomy bleeding - recorded by team member blinded to technique at time of post-operative follow up Day 28 +/-7 .
Timepoint [3] 405357 0
Up to day 14 post-operatively
Secondary outcome [4] 405358 0
Hospital readmission recorded by team member blinded to technique at time of post-operative follow up Day 28 +/-7 .
Timepoint [4] 405358 0
Up to day 14 post-operatively
Secondary outcome [5] 405359 0
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 .
Timepoint [5] 405359 0
Up to day 14 post-operatively
Secondary outcome [6] 405360 0
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 .
Timepoint [6] 405360 0
Up to day 14 post-operatively
Secondary outcome [7] 405361 0
Oxycodone use - - recorded by patient or carer and reported to surgeon blinded to technique at time of post-operative follow up Day 28 +/-7 .
Timepoint [7] 405361 0
Up to day 14 post-operatively
Secondary outcome [8] 405362 0
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 .
Timepoint [8] 405362 0
Up to day 14 post-operatively

Eligibility
Key inclusion criteria
Assigned for tonsillectomy +/- adenoidectomy +/- grommets due to recurrent tonsillitis or sleep disordered breathing
Available for ongoing follow up and review

Minimum age
3 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be concealed within sequentially numbered, opaque, and sealed and stapled envelopes that are impermeable to light. Corresponding envelopes will only be opened after the enrolled participants completed all baseline assessments, is in theatre and it is time to allocate the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be created using Excel Microsoft 365 with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 68 (34 participants in each group) will have 95% power to detect a difference in means of 0.51, assuming a standard deviation of differences of 0.57, using a t-test with a 0.05 two-sided significance level. To account for incomplete data and dropouts the sample size was increased to 100 participants: 50 BizactTM and 50 bipolar diathermy tonsillectomies.

Descriptive statistics and graphic visualization of the study population will be presented. For continuous variables, measures of central tendencies (mean, median) and distribution (SD and IQR) will be reported. For all normally distributed variables, means and standard deviations will be used for reporting purposes. Variables not normally distributed will be presented using medians and inter-quartile range (IQR). Normality will be assessed using the Shapiro-Wilk’s test and visualization by Q-Q plots. Frequencies and proportions will be presented for categorical variables. Chi-square (or Fisher’s Exact test where appropriate) will be used to examine the difference between groups for categorical outcome variables. T-test (or Mann-Whitney U test non-normal data) will be used to analyse the differences between groups for continuous outcome variables. In order to explore the differences in post-operative pain at various time-points, linear mixed model analyses will be conducted. Separate random intercept models with interaction terms between type of tonsillectomy, operating surgeon, surgery type and time will be built with time as fixed effect and subjects (patients) as random effects. Post-hoc analysis will be performed for pairwise comparison between time-points and each variable of interest.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/03/2022
Actual
Date of last participant enrolment
Anticipated
4/01/2023
Actual
Date of last data collection
Anticipated
7/02/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21311 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 36192 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 310457 0
Hospital
Name [1] 310457 0
Queensland Childrens Hospital and Health Service
Country [1] 310457 0
Australia
Primary sponsor type
Individual
Name
Jemma Porrett
Address
Queensland Children's Hospital - 501 Stanley St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 311602 0
None
Name [1] 311602 0
NONE
Address [1] 311602 0
NONE
Country [1] 311602 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310017 0
Childrens Health Queensland Hospital and Health Service
Ethics committee address [1] 310017 0
501 Stanley Street
South Brisbane
Queensland 4101
Ethics committee country [1] 310017 0
Australia
Date submitted for ethics approval [1] 310017 0
15/01/2021
Approval date [1] 310017 0
Ethics approval number [1] 310017 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116194 0
Dr Jemma Porrett
Address 116194 0
Queensland Childrens Hospital, 501 Stanley St, South Brisbane QLD 4101
Country 116194 0
Australia
Phone 116194 0
+61 7 3068 4508
Fax 116194 0
Email 116194 0
[email protected]
Contact person for public queries
Name 116195 0
Dr Jemma Porrett
Address 116195 0
Queensland Childrens Hospital 501 Stanley St, South Brisbane QLD 4101
Country 116195 0
Australia
Phone 116195 0
+61 7 3068 4508
Fax 116195 0
Email 116195 0
[email protected]
Contact person for scientific queries
Name 116196 0
Dr Jemma Porrett
Address 116196 0
Queensland Childrens Hospital 501 Stanley St, South Brisbane QLD 4101
Country 116196 0
Australia
Phone 116196 0
+61 7 3068 4508
Fax 116196 0
Email 116196 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.