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Trial registered on ANZCTR


Registration number
ACTRN12616001672448p
Ethics application status
Not yet submitted
Date submitted
1/12/2016
Date registered
5/12/2016
Date last updated
3/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of sucralfate as an analgaesic adjunct in paediatric tonsillectomy
Scientific title
Effectiveness of the use of sucralfate as an analgaesic adjunct in paediatric tonsillectomy using the Parents Postoperative Pain Measure to assess pain
Secondary ID [1] 290666 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12615001354572
Pilot study assessing feasability and tolerability of same compound

Health condition
Health condition(s) or problem(s) studied:
Management of post tonsillectomy pain in paediatric populations 301198 0
Condition category
Condition code
Surgery 300952 300952 0 0
Other surgery
Anaesthesiology 300953 300953 0 0
Pain management
Oral and Gastrointestinal 300954 300954 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] 296547 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] 300370 0
Parent's Postoperative Pain Measure
Timepoint [1] 300370 0
Assessed daily for 7 days postoperatively
Primary outcome [2] 300373 0
Functional Limitation Scale
Timepoint [2] 300373 0
Assessed daily for 7 days postoperatively
Secondary outcome [1] 329809 0
FACES Pain Scale - Revised
Timepoint [1] 329809 0
Assessed daily for 7 days postoperatively
Secondary outcome [2] 329810 0
Requirement for unplanned contact with medical practitioners, assessed by parent report at phone interview
Timepoint [2] 329810 0
Within the first 7 days post-operatively
Secondary outcome [3] 329811 0
Incidence of known side effects of sucralfate such as constipation, nausea, dry mouth, headache, vomiting, urticarial rash, dizziness, back pain, gastric bezoar, aluminium toxicity or hypophosphataemia and any other previously unidentified side effects. These will be assessed based on parental report.
Timepoint [3] 329811 0
Assessed daily for 7 days postoperatively
Secondary outcome [4] 329812 0
Parent’s rating of child’s sleep quality
Parents will be asked whether their child slept normally the previous night
Timepoint [4] 329812 0
Assessed daily for 7 days postoperatively
Secondary outcome [5] 329813 0
Tolerability of mixture
This will be judged based on the number of doses refused by children as assessed by parent report
Timepoint [5] 329813 0
Assessed daily for 7 days postoperatively
Secondary outcome [6] 329814 0
Analgesia given
This will be judged based on parent report of number of doses of each type of analgesia provided to their children
Timepoint [6] 329814 0
Assessed daily for 7 days postoperatively

Eligibility
Key inclusion criteria
Children aged 4-12
Undergoing tonsillectomy at Casey Hospital or Monash Medical Centre
ASA 1/2 or 3 if solely due to severe obstructive sleep apnoea with no sequalae
Minimum age
4 Years
Maximum age
12 Years
Sex
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

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 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7037 0
Casey Hospital - Berwick
Recruitment hospital [2] 7038 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 14769 0
3806 - Berwick
Recruitment postcode(s) [2] 14770 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 295097 0
Hospital
Name [1] 295097 0
Casey Hospital
Country [1] 295097 0
Australia
Primary sponsor type
Hospital
Name
Casey Hospital
Address
62-70 Kangan Drive
Berwick 3806 VIC
Country
Australia
Secondary sponsor category [1] 293915 0
None
Name [1] 293915 0
None
Address [1] 293915 0
None
Country [1] 293915 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296446 0
The Monash Health Human Research Ethics Committee
Ethics committee address [1] 296446 0
246 Clayton Rd, Clayton VIC 3168
Ethics committee country [1] 296446 0
Australia
Date submitted for ethics approval [1] 296446 0
18/01/2017
Approval date [1] 296446 0
Ethics approval number [1] 296446 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.

For this trial, 170 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 gargle 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 70894 0
Dr Anna Englin
Address 70894 0
Anaesthetics Department
Monash Medical Centre
246 Clayton Road
Clayton, 3168 VIC
Country 70894 0
Australia
Phone 70894 0
+61395946666
Fax 70894 0
Email 70894 0
[email protected]
Contact person for public queries
Name 70895 0
Dr Anna Englin
Address 70895 0
Anaesthetics Department
Monash Medical Centre
246 Clayton Road
Clayton, 3168 VIC
Country 70895 0
Australia
Phone 70895 0
+61395946666
Fax 70895 0
Email 70895 0
[email protected]
Contact person for scientific queries
Name 70896 0
Dr Anna Englin
Address 70896 0
Anaesthetics Department
Monash Medical Centre
246 Clayton Road
Clayton, 3168 VIC
Country 70896 0
Australia
Phone 70896 0
+61395946666
Fax 70896 0
Email 70896 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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