MedTrace Logo

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

NCT07345819 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Orbital Cellulitis

Interventions

DRUG

Dexamethasone 0.3mg/kg

SANDOZ-DEXAMETHASONE SODIUM PHOSPHATE INJ USP 4MG/ML (5 mL vial) (DIN# 00664227) or any brand available commercially in the Canadian market. Dexamethasone 0.3 mg/kg (max dose 12 mg) will be given by IV after randomization. The second dose will be given 24 hours (+/-8 hours) after the first dose. The most recent weight recorded in the patient's chart will be used for the dose calculation.

DRUG

Placebo Control

Sodium Chloride 0.9% Injection USP Placebo Baxter brand (or any commercially available in the Canadian market) given by IV, first dose administered after randomization and second dose 24 hours (+/- 8 hours) after the first.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Peter J Gill, MD, DPhil · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07345819 on ClinicalTrials.gov