RecruitingPhase 3ACTRN12621001390875

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


Sponsor

Gosford Hospital

Enrollment

140 participants

Start Date

Feb 25, 2022

Study Type

Interventional

Conditions

Summary

Pain after tonsillectomy is widely recognised to be not fully controlled by current pain management methods, especially in children. The aim of the study is to find out whether the use of the medication celecoxib will be useful in reducing this pain. The hypothesis is that celecoxib will be safe and effective to manage pain in children after tonsillectomy.


Eligibility

Sex: Both males and femalesMin Age: 3 YearssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Tonsillectomy (removal of the tonsils) is one of the most common operations performed in children, but the pain afterwards is notoriously difficult to control. Standard pain management — including paracetamol and opioids — often doesn't fully eliminate the discomfort, which can interfere with eating, drinking, and recovery. Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen are sometimes avoided in tonsillectomy due to concerns about bleeding, but some newer NSAIDs like celecoxib may offer a safer alternative. This double-blind, placebo-controlled trial will compare celecoxib against placebo (on top of standard care) in children aged 3 to 16 having tonsillectomy, to determine whether celecoxib provides better pain control safely. Pain scores, medication use, and side effects will be carefully monitored. Your child may be eligible if they are aged 3 to 16 and are scheduled for a tonsillectomy with or without adenoidectomy. Children with known allergies to NSAIDs, opioids, paracetamol, or sulphonamides, significant comorbidities, those already taking these medications regularly, or children with a history of peptic ulcers or gastrointestinal bleeding are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 fo

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.


Locations(2)

Gosford Hospital - Gosford

NSW, Australia

Gosford Private Hospital - Gosford

NSW, Australia

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ACTRN12621001390875