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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001390875
Enrollment
44
Registered
2021-10-15
Start date
2022-02-25
Completion date
2023-11-01
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Sponsors

Gosford Hospital
Lead SponsorHospital

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
3 Years to 16 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026