Use of sucralfate as an analgaesic adjunct in paediatric tonsillectomy

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001672448
• Date of registration: 05/12/2016
• Prospective Registration: Yes
• Primary sponsor: Casey Hospital
• 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
• Date of first enrolment: 15/01/2018
• Target sample size: 170
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616001672448.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2 / Phase 3

Countries of recruitment

Australia

Contacts

• Name: Dr Anna Englin

• Name: Dr Anna Englin

Key inclusion & exclusion criteria

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

Age minimum: 4 Years
Age maximum: 12 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Management of post tonsillectomy pain in paediatric populations;
Management of post tonsillectomy pain in paediatric populations

Surgery - Other surgery

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Anaesthesiology - Pain management

Intervention(s)

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.

Primary Outcome(s)

Functional Limitation Scale[Assessed daily for 7 days postoperatively]

Parent's Postoperative Pain Measure[Assessed daily for 7 days postoperatively]

Secondary Outcome(s)

Parent’s rating of child’s sleep quality
Parents will be asked whether their child slept normally the previous night[Assessed daily for 7 days postoperatively]

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.
[Assessed daily for 7 days postoperatively]

Requirement for unplanned contact with medical practitioners, assessed by parent report at phone interview[Within the first 7 days post-operatively]

Analgesia given
This will be judged based on parent report of number of doses of each type of analgesia provided to their children[Assessed daily for 7 days postoperatively]

Tolerability of mixture
This will be judged based on the number of doses refused by children as assessed by parent report[Assessed daily for 7 days postoperatively]

FACES Pain Scale - Revised[Assessed daily for 7 days postoperatively]

Secondary ID(s)

None

Source(s) of Monetary Support

Casey Hospital

Ethics review

Status: Not approved
Approval date:
Contact:

The Monash Health Human Research Ethics Committee