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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001096347
Ethics application status
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Approved
Date submitted
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18/02/2026
Date registered
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4/09/2026
Date last updated
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4/09/2026
Date data sharing statement initially provided
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4/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Comparing paracetamol, ibuprofen and celecoxib for reducing inflammation and supporting wound healing in children with burn injuries: a pilot randomised controlled trial
Scientific title
The Effect of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on Inflammation in Children with Burn Injuries: A Pilot Randomised Controlled Trial
Additional trial identifiers [1] 316565 0
NILL
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Burn Injury 340727 0
Inflammation 340728 0
Condition category
Condition code
Injuries and Accidents 336917 336917 0 0
Burns
Inflammatory and Immune System 336918 336918 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will be randomised in a 1:1:1 ratio to one of three treatment groups: (1) standard care with paracetamol, (2) standard care plus celecoxib, or (3) standard care plus ibuprofen. Study medications will be administered orally for five days. Other routine analgesia, including opioid analgesia during dressing changes or procedures, may be administered when clinically indicated.

Standard care – paracetamol: Paracetamol will be administered orally at 15 mg/kg per dose, to a maximum of 1,000 mg per dose, four times daily at intervals of 4–6 hours. The dose will be calculated using the participant's ideal body weight at the start of treatment.

Celecoxib intervention: Celecoxib will be administered orally at 4 mg/kg per dose, to a maximum of 200 mg per dose, twice daily at intervals of 6–12 hours for five days. The dose will be calculated using the participant's weight recorded on the first day of celecoxib administration. Participants will also receive paracetamol as described above. Celecoxib will be supplied as 200 mg capsules. For doses below 200 mg or for participants unable to swallow a capsule, the capsule contents will be dispersed in 20 mL of water. The required dose will be drawn into an oral dosing device and administered, with any remaining preparation discarded.

Ibuprofen intervention: Ibuprofen oral suspension, 100 mg/5 mL (20 mg/mL), will be administered orally at 10 mg/kg per dose, to a maximum of 400 mg per dose, three times daily at intervals of 6–8 hours for five days. The dose will be calculated using the participant's weight recorded on the first day of ibuprofen administration. Participants will also receive paracetamol as described above.

Caregivers will receive written dosing instructions, a calibrated oral syringe and a medication diary. They will record the date and time of each study medication dose and any other medications administered. The medication diary will be reviewed by the research team to monitor adherence. Medication administration occurring in hospital will also be documented in the participant's medication administration record.
Intervention code [1] 333244 0
Treatment: Drugs
Intervention code [2] 334792 0
Prevention
Description of the comparator or control
Participants in the control arm will receive standard burn care, including routine wound management and analgesia as per hospital protocol (typically paracetamol and/or opioid analgesia as clinically required), without adjunctive celecoxib. This reflects current standard clinical practice for paediatric burn pain and inflammation management.
Control group
Active

Outcomes
Primary outcome [1] 344438 0
(a) Primary Outcomes - Composite safety outcome associated with non-steroidal anti-inflammatory drug treatment
Timepoint [1] 344438 0
From baseline before administration of the first study medication dose, throughout the five-day treatment period, and at each routine clinical contact up to 12 months after enrolment.
Secondary outcome [1] 457943 0
(b) Secondary Outcomes 1. Systemic inflammatory response, Change in systemic inflammatory response
Timepoint [1] 457943 0
Baseline prior to the first study medication dose; during the five-day treatment period when samples are collected during routine wound-care appointments; and during subsequent routine clinical follow-up appointments, up to 12 months after enrolment.
Secondary outcome [2] 457944 0
3. Pain intensity, Change in pain intensity associated with wound-care procedures.
Timepoint [2] 457944 0
Immediately before and immediately after each wound-care procedure occurring during the five-day treatment period.
Secondary outcome [3] 465454 0
4. Wound healing, Outcome: Time to 95% burn-wound re-epithelialisation
Timepoint [3] 465454 0
Assessed at each routine dressing change from enrolment until 95% re-epithelialisation is achieved.
Secondary outcome [4] 465455 0
5. Requirement for skin grafting. Outcome: Requirement for surgical skin grafting
Timepoint [4] 465455 0
From enrolment until wound closure or 12 months after enrolment, whichever occurs first.
Secondary outcome [5] 465456 0
6. Scar quality and formation. Burn-scar quality and impact. This will be assessed as a composite secondary outcome.
Timepoint [5] 465456 0
Approximately three months after the burn injury during a routine burn or scar-clinic appointment.
Secondary outcome [6] 465457 0
7. Post-traumatic stress symptoms. Post-traumatic stress symptoms and severity. This will be assessed as a composite outcome.
Timepoint [6] 465457 0
Three months after the burn injury.

Eligibility
Key inclusion criteria
(a) Inclusion criteria
• Patients aged 2–16 years presenting to Queensland Children’s Hospital (QCH) with an acute thermal burn injury.
• Patients admitted within 48 hours post-burn injury.
• Patients who will be sedated or under a general anaesthetic with a cannula inserted for surgical procedures, including: debridement and wound cleaning, dressing changes, surgical grafting, surgical wound management or scar revision, as these will enable the collection of blood.
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
(b) Exclusion criteria
Conditions
• Autoimmune Disorders: Patients with known autoimmune diseases, such as lupus or juvenile idiopathic arthritis, due to potential interference with inflammatory responses and healing processes.
• Hematologic Disorders: Individuals with bleeding disorders (e.g., hemophilia, thrombocytopenia) or those on anticoagulant therapy, as these conditions may complicate wound healing and increase bleeding risks.
• Gastrointestinal Conditions: Patients with active GI diseases (e.g., peptic ulcers, inflammatory bowel disease) that could be exacerbated by NSAID use.
• Renal Impairment: Children with pre-existing kidney disease or acute kidney injury, as NSAIDs can affect renal function.
• Hepatic Dysfunction: Patients with liver disease or elevated liver enzymes, as NSAIDs are metabolized hepatically and may exacerbate liver dysfunction.
• Known NSAID Hypersensitivity: Children with a history of allergic reactions to NSAIDs, including celecoxib, to prevent adverse reactions.
• Patient with infections to be excluded.
• Delayed presentations to be excluded – admitted to hospital 3 or more days post burn injury.
• Patients on the following prescribed medications: Aspirin, Angiotensin-converting enzyme (ACE) inhibitors, Angiotensin receptors, Beta-blockers, Diuretics, Digoxin, Lithium, Methotrexate, Cyclosporine, Pemetrexed, Corticosteroids,
• Concurrent medications that may interact with celecoxib (CYP2C9 inhibitors or inducers)
a. CYP2C9 inhibitors: amiodarone, asciminib, benzbromarone, ceritinib, efavirenz, etravirine, fluconazole, fluoxetine, fluvoxamine, miconazole (systemic), ritonavir, voriconazole
b. CYP2C9 inducers: apalutamide, aprepitant, bosentan, carbamazepine, dabrafenib, enzalutamide, rifampicin, ritonavir, St John’s wort
• Allergy to sulfonamides
• Heart failure (NYHA class II–IV), angina, peripheral arterial disease or cerebrovascular disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved using the Griffith University Randomisation Service. A secure, computer-generated randomisation sequence will be generated and stored independently of the research team. Allocation will occur only after eligibility is confirmed and informed consent has been obtained. Group assignments will be revealed only at the time of enrolment, ensuring investigators cannot predict future allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence will be generated using the Griffith University Randomisation Service. Participants will be allocated in a 1:1:1 ratio to one of three treatment groups (paracetamol, celecoxib, or ibuprofen).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a pilot study, a formal power calculation has not been conducted. The primary aim is to assess safety, feasibility, recruitment rates, and preliminary effect sizes to inform the design and sample size of a future larger trial. A target of approximately 60 participants (20 per group) has been chosen as it is typical for pilot studies and is expected to provide sufficient data to estimate variability and refine the methodology for subsequent studies.
a) Statistical methods
• Summarised descriptives of baseline characteristics (age, burn size, depth, etc.) by treatment groups using means (±SD), or proportions as appropriate.
• Compare baseline balance between arms using t-tests or Mann-Whitney U for continuous variables, chi-square or Fisher’s exact tests for categorical variables.
• Use a mixed-effects linear model (or repeated-measures ANOVA / linear mixed model) to compare change in markers over time between groups, adjusting for baseline values. Potential covariates: burn surface area, depth, age, etc.
Binary and continuous Generalised Linear Models (for cross sectional, single point data) and mixed models/Generalised Estimating Equations (for longitudinal) will be used (co-variates: collection site, burn depth, burn size, burn mechanism, age). Adjustment for multiple, dependent variables will be considered using Benjamini Hochberg procedure. y

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2026
Actual
Date of last participant enrolment
Anticipated
7/09/2027
Actual
Date of last data collection
Anticipated
7/09/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 29146 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 45452 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 321181 0
University
Name [1] 321181 0
Griffith University
Country [1] 321181 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 323887 0
None
Name [1] 323887 0
Address [1] 323887 0
Country [1] 323887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319717 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 319717 0
Ethics committee country [1] 319717 0
Australia
Date submitted for ethics approval [1] 319717 0
18/02/2026
Approval date [1] 319717 0
15/07/2026
Ethics approval number [1] 319717 0
HREC/25/QCHQ/123877

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148162 0
Prof Bronwyn Griffin
Address 148162 0
Centre for Children Health Research, 62 Graham St, South Brisbane, QLD, 4101
Country 148162 0
Australia
Phone 148162 0
+61404892517
Fax 148162 0
Email 148162 0
[email protected]
Contact person for public queries
Name 148163 0
Donna Langley
Address 148163 0
Centre for Children Health Research, 62 Graham St, South Brisbane, QLD, 4101
Country 148163 0
Australia
Phone 148163 0
+61415111582
Fax 148163 0
Email 148163 0
[email protected]
Contact person for scientific queries
Name 148164 0
Donna Langley
Address 148164 0
Centre for Children Health Research, 62 Graham St, South Brisbane, QLD, 4101
Country 148164 0
Australia
Phone 148164 0
+61415111582
Fax 148164 0
Email 148164 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    approval 150726.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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