Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis

Summary

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.

Timeline

Start

2026-04-01

Primary completion

2027-09-30

Completion

2027-12-31

Publications

• Background Gonsalves CL, Borkhoff C, Mahant S, Drouin O, Pound C, Quet J, Wahi G, Bayliss A, Vomiero G, Foulds JL, Kanani R, Sakran M, Sehgal A, Pullenayegum E, Widjaja E, Reginald A, Wolter NE, Parkin PC, Gill PJ; Periorbital and Orbital Cellulitis (POC) Multicentre Study Group and Canadian Paediatric Inpatient Research Network (PIRN). Association of systemic corticosteroids and clinical outcomes in children hospitalised with severe orbital infections. BMJ Paediatr Open. 2025 Dec 11;9(1):e004161. doi: 10.1136/bmjpo-2025-004161.
• Background Kornelsen E, Mahant S, Parkin P, Ren LY, Reginald YA, Shah SS, Gill PJ. Corticosteroids for periorbital and orbital cellulitis. Cochrane Database Syst Rev. 2021 Apr 28;4(4):CD013535. doi: 10.1002/14651858.CD013535.pub2.
• Background Gill PJ, Mahant S, Hall M, Parkin PC, Shah SS, Wolter NE, Mestre M, Markham JL. Association Between Corticosteroids and Outcomes in Children Hospitalized With Orbital Cellulitis. Hosp Pediatr. 2022 Jan 1;12(1):70-89. doi: 10.1542/hpeds.2021-005910.

Drugs

Indications