Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001390875
Ethics application status
Approved
Date submitted
29/08/2021
Date registered
15/10/2021
Date last updated
31/08/2023
Date data sharing statement initially provided
15/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of celecoxib in postoperative analgesia in paediatric tonsillectomy: a double-blinded, placebo-controlled randomised controlled trial
Scientific title
Role of celecoxib in postoperative analgesia in paediatric tonsillectomy: a double-blinded, placebo-controlled randomised controlled trial
Secondary ID [1] 305150 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric tonsillectomy 323412 0
Condition category
Condition code
Surgery 320966 320966 0 0
Other surgery
Anaesthesiology 320983 320983 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Celecoxib at dose of 2mg per kg of body weight, taken twice daily, orally in liquid form for 14 days
AND
Paracetamol at dose of 15mg per kg of body weight, four times a day, orally in liquid form for 14 days
AND
Oxycodone liquid orally, at 0.1mg per kg of body weight, as required (up to four times a day)

These medications will be started on the day of tonsillectomy. Adherence will be monitored by self-report by the patients and/or their guardians on the questionnaires.
Intervention code [1] 321557 0
Treatment: Drugs
Comparator / control treatment
Paracetamol at dose of 15mg per kg of body weight, four times a day, orally in liquid form for 14 days
AND
Oxycodone liquid orally, at 0.1mg per kg of body weight, as required (up to four times a day)
AND
De-identified bottle of similarly appearing, pharmacologically inactive placebo orally, as distributed by Gosford Pharmacy. The composition of the placebo is the inert suspension base as used for the celecoxib mixture.

These medications will be started on the day of the tonsillectomy.
Control group
Active

Outcomes
Primary outcome [1] 328738 0
“Average pain on that postoperative day” as reported on a Wong-Baker FACES pain rating scale where 0 is “no pain at all” and 10 is “the worst pain I’ve ever felt”. This will be self-reported by all the participants aged greater than 5 years and with parent guidance in children aged 3 or 4 years.
Mode of self-reporting will be via study-specific online questionnaire.
Timepoint [1] 328738 0
1, 3, 5, 7 (primary timepoint), 10 and 14 post-operative day
Secondary outcome [1] 400204 0
Amount of oxycodone used per day, in doses/day; assessed using self-reported data from study-specific questionnaire
Timepoint [1] 400204 0
1, 3, 5, 7, 10 and 14 post-operative day
Secondary outcome [2] 400205 0
First post-operative day without pain, assessed using the Wong-Baker Scale as part of the study-specific questionnaire.
Timepoint [2] 400205 0
1, 3, 5, 7, 10 and 14 post-operative day
Secondary outcome [3] 412131 0
Number and incidence of adverse events experienced, such as nausea, vomiting, diarrhoea, constipation, bleeding or drowsiness. This will be collected via questionnaire in days specified.
The questionnaire has been developed specifically for this study.
Timepoint [3] 412131 0
Day 1, 3, 5, 7, 10, 14 post-operatively

Eligibility
Key inclusion criteria
Patients aged 3-16 years
Patients undergoing tonsillectomy with or without adenoidectomy
Minimum age
3 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients:
*Allergy to non-steroidal anti-inflammatory drugs (NSAIDs), opioids, paracetamol, or sulphonamides
*Significant comorbidities unfit for treatment with selected intervention
*Already taking NSAIDs, opioids or paracetamol on a regular basis
*Patients taking drugs that interact with opioids, paracetamol or NSAIDs
*History of peptic ulcers or gastrointestinal bleeding
*Females who are pregnant or nursing

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)
Randomised allocations will be delivered to administration staff in sealed white envelopes with no distinguishing features containing a randomisation number. Researchers who will be undertaking data collection and the operating doctors will have no knowledge of the allocation groups. The surgical team will prescribe either the intervention or the control measures according to randomisation. Patients and their guardians will know their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to either control or experimental group with a 1:1 allocation as per a computer generated randomisation sequence stratified by age and gender (block randomisation). Block sizes will not be disclosed, to ensure concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic and clinical characteristics of randomised patients will be summarised by group. Numeric variables will be reported as mean with standard deviation or median with interquartile range (IQR) if skewed. Categorical variables will be reported as frequency count and percentage. Pain scores will be summarised by group at days 1, 3, 5, 7, 10, and 14.

The primary outcome will be reported as the mean difference with 95% confidence interval in post-operative pain score at Day 7 (intervention versus control) and will be analysed using a t-test and a linear regression adjusted for gender and age group. All patients with non-missing outcome data will be included in the analysis and patients will be analysed according to their randomised group allocation as per the intention-to-treat (ITT) principle.

Secondary outcomes will be compared between groups using chi-squared tests/logistic regression for binary outcomes (such as Day 14 postoperative bleeding) or log-rank tests/Cox regression for time-to-event outcomes (such as first pain-free day).

A sensitivity analysis for compliance will be conducted for the primary outcome. Safety data will be reported per group as total number of adverse events, number of participants with adverse event(s), and number of events by severity category. All analyses will be conducted at a significance level of 0.05. Analysis will be performed in SAS (Cary, NC) or SPSS (Chicago, IL) or JAMOVI. Statistical analysis will be performed using the Stata program. Excel will be used for graph construction. Data analysis will be reviewed by statisticians affiliated with UON.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
25/02/2022
Date of last participant enrolment
Anticipated
1/11/2023
Actual
Date of last data collection
Anticipated
15/11/2023
Actual
Sample size
Target
140
Accrual to date
44
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20423 0
Gosford Hospital - Gosford
Recruitment hospital [2] 20424 0
Gosford Private Hospital - Gosford
Recruitment postcode(s) [1] 35181 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 309540 0
University
Name [1] 309540 0
University of Newcastle
Country [1] 309540 0
Australia
Primary sponsor type
Hospital
Name
Gosford Hospital
Address
Holden St, Gosford NSW 2250
Country
Australia
Secondary sponsor category [1] 310535 0
None
Name [1] 310535 0
Address [1] 310535 0
Country [1] 310535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309321 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309321 0
Ethics committee country [1] 309321 0
Australia
Date submitted for ethics approval [1] 309321 0
29/08/2021
Approval date [1] 309321 0
08/10/2021
Ethics approval number [1] 309321 0
2021/ETH11236

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

Contacts
Principal investigator
Name 113754 0
Dr Shashinder Singh
Address 113754 0
Gosford Hospital, Holden St, Gosford NSW 2250
Country 113754 0
Australia
Phone 113754 0
+61 2 4320 2019
Fax 113754 0
Email 113754 0
[email protected]
Contact person for public queries
Name 113755 0
Chloe Douglas
Address 113755 0
Gosford Hospital, Holden St, Gosford NSW 2250
Country 113755 0
Australia
Phone 113755 0
+61 466360342
Fax 113755 0
Email 113755 0
[email protected]
Contact person for scientific queries
Name 113756 0
Michael Zhang
Address 113756 0
Gosford Hospital, Holden St, Gosford NSW 2250
Country 113756 0
Australia
Phone 113756 0
+61 414658119
Fax 113756 0
Email 113756 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
All analysis will be done as a group, so any incidental findings will be relevant as a cohort and not as individuals. Thus, each participant will be de-identified, with no direct results of any one patient be singled out. Their demographic details and outcomes of interest will undergo extensive analysis before publication and be regarded as a group, not individually.


What supporting documents are/will be available?




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.