None listed
Conditions
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.
Interventions
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.
Sponsors
Casey Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Healthy volunteers
No
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
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
Outcome results
None listed