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Trial registered on ANZCTR


Registration number
ACTRN12615001354572
Ethics application status
Approved
Date submitted
8/12/2015
Date registered
14/12/2015
Date last updated
4/03/2020
Date data sharing statement initially provided
4/03/2020
Date results information initially provided
4/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of sucralfate as an analgaesic adjunct in paediatric tonsillectomy (pilot)
Scientific title
Feasibility and tolerability of the use of sucralfate as an analgaesic adjunct in paediatric tonsillectomy using the Parents Postoperative Pain Measure to assess pain (pilot)
Secondary ID [1] 288098 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
management of post tonsillectomy pain in paediatric populations 296959 0
Condition category
Condition code
Surgery 297220 297220 0 0
Other surgery
Anaesthesiology 297230 297230 0 0
Pain management
Oral and Gastrointestinal 297231 297231 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both control and experimental subjects will receive the standard pain management protocol (paracetamol 15 mg/kg QID, ibuprofen 5 mg/kg QID). In addition, the patients
will be provided with sucralfate (or placebo). The sucralfate solution will be made up to 2 grams in 50 mL of a 1:1 combination of ORA-Sweet and ORA-Plus (a proprietary drug suspension solution) while the placebo will consist of a 1:1 combination of ORA Sweet and ORA-Plus with no further additives.

After each set of doses of ibuprofen and paracetamol (four times a day), 5 mL of the study mixture will be gargled and swallowed by the child for the first seven days post-operatively.

Parents will be asked to report frequency of provision of each drug.
Intervention code [1] 293405 0
Treatment: Drugs
Comparator / control treatment
Drug suspension vehicle with no additives (ORA-Sweet/ORA-Plus 1:1)
Control group
Placebo

Outcomes
Primary outcome [1] 296808 0
Tolerability of drug to children (based on percentage of time children refusing medication). This is assessed by parent report in a study diary and follow-up phone contact.
Timepoint [1] 296808 0
For seven days post-operatively
Secondary outcome [1] 319414 0
Incidence of side effects

Known side effects include constipation, thirst, rashes, dizziness and sleepiness. These will be assessed on parental report.

Aluminium toxicity is a known side effect in renal failure, but we do not expect this to occur with the exclusion of all patients with renal impairment.
Timepoint [1] 319414 0
7 days post-operatively
Secondary outcome [2] 319415 0
Parents Postoperative Pain Measure
Timepoint [2] 319415 0
Assessed daily for 7 days postoperatively
Secondary outcome [3] 319416 0
Functional Limitation Scale (FLS)
Timepoint [3] 319416 0
Assessed daily for 7 days postoperatively
Secondary outcome [4] 319417 0
FACES Pain Scale – Revised (FPS-R)
Timepoint [4] 319417 0
Assessed daily for 7 days postoperatively
Secondary outcome [5] 319418 0
Parent’s rating of child’s sleep quality
Parents will be asked whether their child slept normally the previous night
Timepoint [5] 319418 0
Assessed daily for 7 days postoperatively
Secondary outcome [6] 319419 0
Analgesia given
This will be assessed based on total dosage given as a percentage of dose recommended in the standard protocol. This will be assessed by parent report in study diary.
Timepoint [6] 319419 0
Assessed daily for 7 days postoperatively
Secondary outcome [7] 319420 0
Requirement for unplanned contact with medical practitioners
This outcome will be recorded firstly on a binary basis and secondarily qualitatively. This is assessed by parent report in a study diary and follow-up phone contact.
Timepoint [7] 319420 0
Within the first seven days postoperatively

Eligibility
Key inclusion criteria
Children aged 4-12
Undergoing tonsillectomy at Casey Hospital
ASA 1 or 2
Minimum age
4 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have known renal impairment with eGFR less than 60 mls/min/1.73m2
Are concurrently taking exogenous thyroid hormones
Have a cognitive impairment, an intellectual disability or a mental illness that would impair communication
Undergo tonsillectomy by cold methods or by coblation
Do not receive intraoperative ropivicaine irrigation

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4868 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 12373 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 292522 0
Hospital
Name [1] 292522 0
Casey Hospital
Address [1] 292522 0
62-70 Kangan Drive
Berwick 3806 VIC
Country [1] 292522 0
Australia
Primary sponsor type
Hospital
Name
Casey Hospital
Address
62-70 Kangan Drive
Berwick 3806 VIC
Country
Australia
Secondary sponsor category [1] 291229 0
None
Name [1] 291229 0
Address [1] 291229 0
Country [1] 291229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293998 0
The Monash Health Human Research Ethics Committee
Ethics committee address [1] 293998 0
246 Clayton Rd, Clayton VIC 3168
Ethics committee country [1] 293998 0
Australia
Date submitted for ethics approval [1] 293998 0
25/11/2015
Approval date [1] 293998 0
08/02/2016
Ethics approval number [1] 293998 0

Summary
Brief summary
Sucralfate has some weak evidence of being effective in the management of posttonsillectomy pain in paediatric populations. However, the current literature is limited and has not reported side effect profiles. This pilot trial aims to identify any major side effects that would prevent the use of sucralfate as adjunct analgaesia.
For this pilot, 10 children will be recruited preoperatively and randomised to either receive sucralfate or placebo solution. This will be in addition to the standard Monash Health posttonsillectomy analgaesia protocol. The children will gargel and swallow 5 mLs of the study mixture four times a day. Parents will be provided with a set of questionnaires to complete for each postoperative day, consisting of the parents’ postoperative
pain measure, the functional limitation scale and the FACES pain scale – revised. They will
also be asked about their child’s quality of sleep, how much analgaesia the child has received, any contact with medical practitioners required, whether their child tolerates the study mixture and any side effects they notice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62042 0
Dr Anna Englin
Address 62042 0
Anaesthetics Department
Monash Medical Centre
246 Clayton Road
Clayton, 3168 VIC
Country 62042 0
Australia
Phone 62042 0
+61412277168
Fax 62042 0
Email 62042 0
aenglin@gmail.com
Contact person for public queries
Name 62043 0
Dr Anna Englin
Address 62043 0
Anaesthetics Department
Monash Medical Centre
246 Clayton Road
Clayton, 3168 VIC
Country 62043 0
Australia
Phone 62043 0
+61412277168
Fax 62043 0
Email 62043 0
aenglin@gmail.com
Contact person for scientific queries
Name 62044 0
Dr Anna Englin
Address 62044 0
Anaesthetics Department
Monash Medical Centre
246 Clayton Road
Clayton, 3168 VIC
Country 62044 0
Australia
Phone 62044 0
+61412277168
Fax 62044 0
Email 62044 0
aenglin@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary