The goal of this pilot randomized controlled trial is to understand whether we can successfully conduct a larger definitive clinical trial in the future. The current pilot study will test various aspects of the larger trial and help us improve its design if needed. The investigators are mainly interested in knowing whether they can (1) recruit enough patients, (2) administer the intervention, and (3) collect all the data needed from patients. The definitive randomized controlled trial will assess if dexamethasone is superior to placebo for treating children and youth hospitalized with orbital cellulitis.
Age 2.00 months -17.99 years (prior to 18th birthday)
Confirmed or suspected diagnosis of orbital cellulitis as determined by the attending physician, medical team, and/or delegate's clinical judgement, based on one or more features of orbital cellulitis (i.e., ophthalmoplegia, pain and/or limitation with extraocular movements, chemosis, blurred vision, eye swollen shut, and/or proptosis).
Scheduled to be admitted or admitted to hospital for less than 36 hours.
Informed consent provided in accordance with institutional policies
Transferred directly from outside hospital inpatient setting to a participating hospital site's inpatient setting with over 36 hours having passed since admission to outside hospital. If within 36 hours, patient is eligible.
Treatment with IV or PO systemic corticosteroids within 1 week of presentation
Recent hospital admission for orbital cellulitis within 1 week of presentation
Current systemic fungal infection
The Hospital for Sick Children
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator