None listed
Conditions
Brief summary
This pilot study will compare three pain-treatment approaches in children aged 2–16 years with burn injuries: standard care with paracetamol, paracetamol plus celecoxib, and paracetamol plus ibuprofen. The study will assess whether celecoxib and ibuprofen can be used safely in these children and whether they reduce inflammation, pain and the time required for burn wounds to heal. It will also examine whether the treatments affect the need for skin grafting, scar outcomes and post-traumatic stress symptoms. We hypothesise that children receiving celecoxib or ibuprofen will have less inflammation and improved healing outcomes compared with children receiving paracetamol alone, without an unacceptable increase in adverse effects.
Interventions
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 1,0
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.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to 16 Years
Healthy volunteers
No
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.
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
Outcome results
None listed