Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001267549
Ethics application status
Approved
Date submitted
30/09/2024
Date registered
16/10/2024
Date last updated
16/10/2024
Date data sharing statement initially provided
16/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing cold and room temperature saline for tonsil removal
Scientific title
Comparing surgical duration and post-operative pain in chilled vs room temperature saline for coblation in paediatric intracapsular tonsillectomy: A randomised controlled trial
Secondary ID [1] 313001 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing with Grade 3 or 4 Tonsillar Hyperplasia 335195 0
Condition category
Condition code
Surgery 331683 331683 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were randomised to either room temperature or chilled saline and underwent intracapsular tonsillectomy (ICT) +/- adenoidectomy via an Evac 70 Coblation wand, for a total procedure time around 15 minutes. Saline was used as the medium for coblation intraoperatively.

Patients meeting clinical indications for ICT were recruited through the Ear, Nose and Throat (ENT) surgeon's clinic and subsequently surgeries were performed by the same ENT surgeon. Post-operatively patients were provided a questionnaire to assess postoperative pain, bleeding and return to normal activity and this was returned at the follow up appointment two weeks following surgery.

Arm 1: 0.9% Room Temperature Saline with temperature of 22.5°C (comparator)
Arm 2: 0.9% Chilled Saline with temperature of 3.8°C (intervention)
Intervention code [1] 329544 0
Treatment: Surgery
Comparator / control treatment
0.9% Room Temperature Saline with temperature of 22.5°C
Control group
Active

Outcomes
Primary outcome [1] 339406 0
Surgical Duration
Timepoint [1] 339406 0
This will be assessed intraoperatively by the operating room staff
Primary outcome [2] 339407 0
Post-operative pain
Timepoint [2] 339407 0
This will be assessed daily from Day 1 postoperatively to Day 14 postoperatively via a questionnaire provided to participants
Secondary outcome [1] 439809 0
Intraoperative Bleeding
Timepoint [1] 439809 0
Measured by the operating staff after the conclusion of the procedure
Secondary outcome [2] 439811 0
Post-operative haemorrhage
Timepoint [2] 439811 0
Assessed based on the presence of any postoperative bleeding for the two week period following surgery. This will be assessed daily by parents and documented on the post-operative questionnaire collected on a subsequent appointment 2-3 weeks post-operatively.
Secondary outcome [3] 439812 0
Return to normal activity
Timepoint [3] 439812 0
Assessed following the procedure via a patient questionnaire that was collected on a subsequent appointment 2-3 weeks post-operatively.

Eligibility
Key inclusion criteria
Those with clinical indication for ICT, specifically sleep disordered breathing with grade 3 or 4 tonsillar hyperplasia.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of anaemia and disorders of haemostasis, velopharyngeal insufficiency, patients with significant craniofacial abnormalities or tongue hypertrophy, previous peri-tonsillar abscess, tonsillotomy performed due to suspicion of malignancy, contraindications to post-surgical analgesia protocol, history of general anaesthetic risk,, and patients on pre-surgery analgesics or other pain-altering medications.

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)
Sealed opaque envelopes were provided to a scrub nurse containing the allocation of the treatment arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined using a power analysis based on a clinically significant difference in surgical duration (deemed 2 minutes) and pain (deemed 1 face (i.e. 2 points) on the Wong-Baker Pain Scale). Power analysis for both outcomes indicated that a sample size of 16 patients per study arm would be required to reach 80% power with a two-sided 5% level of significance. Accounting for anticipated participant drop out and loss to follow up, a target population of 42 patients was determined to fulfil both primary outcome measures.

All statistical analysis was completed in RStudio 2024.04.2. Data was found to be nonparametric and Mann Whitney U tests were conducted. A Chi-square test and Fisher’s exact test were used to measure significance in categorical variables

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/03/2023
Date of last participant enrolment
Anticipated
Actual
20/04/2024
Date of last data collection
Anticipated
Actual
27/05/2024
Sample size
Target
42
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27171 0
Flinders Private Hospital - Bedford Park
Recruitment postcode(s) [1] 43253 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 317440 0
University
Name [1] 317440 0
Flinders University Advanced Studies Stipend
Country [1] 317440 0
Australia
Primary sponsor type
Individual
Name
Prof. Simon Carney - Adelaide Specialist Group, Flinders Private Hospital
Address
Country
Australia
Secondary sponsor category [1] 319730 0
Individual
Name [1] 319730 0
Nishan Chahal - College of Medicine and Public Health, Flinders University
Address [1] 319730 0
Country [1] 319730 0
Australia
Secondary sponsor category [2] 319795 0
Individual
Name [2] 319795 0
James Fowler - College of Medicine and Public Health, Flinders University
Address [2] 319795 0
Country [2] 319795 0
Australia
Secondary sponsor category [3] 319796 0
Individual
Name [3] 319796 0
Hamish Mckenzie - College of Medicine and Public Health, Flinders University
Address [3] 319796 0
Country [3] 319796 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316158 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 316158 0
Ethics committee country [1] 316158 0
Australia
Date submitted for ethics approval [1] 316158 0
13/04/2022
Approval date [1] 316158 0
17/10/2022
Ethics approval number [1] 316158 0
2022/HRE00099

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136974 0
Prof Simon Carney
Address 136974 0
Adelaide Specialist Group, Flinders Private Hospital - Flinders Dr, Bedford Park SA 5042
Country 136974 0
Australia
Phone 136974 0
+61 7 8277 0288
Fax 136974 0
Email 136974 0
[email protected]
Contact person for public queries
Name 136975 0
Simon Carney
Address 136975 0
Adelaide Specialist Group, Flinders Private Hospital - Flinders Dr, Bedford Park SA 5042
Country 136975 0
Australia
Phone 136975 0
+61 7 8277 0288
Fax 136975 0
Email 136975 0
[email protected]
Contact person for scientific queries
Name 136976 0
Simon Carney
Address 136976 0
Adelaide Specialist Group, Flinders Private Hospital - Flinders Dr, Bedford Park SA 5042
Country 136976 0
Australia
Phone 136976 0
+61 7 8277 0288
Fax 136976 0
Email 136976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant data collected during the trial is available after de-identification pending ethical approval.
When will data be available (start and end dates)?
No start and end date determined, will be based on ethical approval.
Available to whom?
Available for researchers providing a methodologically sound proposal.
Available for what types of analyses?
Meta-analysis purposes.
How or where can data be obtained?
Available through contacting the authors via the clinic email [email protected].


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.