Role of celecoxib in postoperative analgesia in paediatric tonsillectomy: a double-blinded, placebo-controlled randomised controlled trial

Interventional Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy; Phase 3 Inclusion criteria: Patients aged 3-16 years Patients undergoing tonsillectomy with or without adenoidectomy 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 Paediatric tonsillectomy; Paediatric tonsillectomy;Surgery - Other surgery;Anaesthesiology - Pain management 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. “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.[1, 3, 5, 7 (primary timepoint), 10 and 14 post-operative day] First post-operative day without pain, assessed using the Wong-Baker Scale as part of the study-specific questionnaire.[1, 3, 5, 7, 10 and 14 post-operative day];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.[Day 1, 3, 5, 7, 10, 14 post-operatively];Amount of oxycodone used per day, in doses/day; assessed using self-reported data from study-specific questionnaire[1, 3, 5, 7, 10 and 14 post-operative day]