Dexamethasone for Orbital Cellulitis
(VISION Pilot Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if dexamethasone, a steroid medication, can effectively treat orbital cellulitis, a serious infection around the eye. It serves as a precursor to a larger study, focusing on enrolling enough participants, administering the treatment correctly, and gathering all necessary information. Participants will receive either dexamethasone or a placebo (an inactive substance) to compare effects. The trial seeks children and teens diagnosed with orbital cellulitis who are scheduled for hospital admission and have been hospitalized for less than 36 hours. As an unphased trial, this study allows participants to contribute to important research that could lead to better treatments for future patients.
Is there any evidence suggesting that dexamethasone is likely to be safe for humans?
Research has shown that using dexamethasone to treat orbital cellulitis appears safe. In children with this condition, adding steroids like dexamethasone may speed recovery and is generally well-tolerated. Although some studies suggest that steroids don't always enhance outcomes, they don't seem to cause harm. This makes dexamethasone a potentially safe option for further exploration in clinical trials.12345
Why are researchers excited about this trial?
Most treatments for orbital cellulitis typically involve antibiotics to tackle the underlying bacterial infection. However, researchers are excited about using dexamethasone because it offers an anti-inflammatory approach that could reduce swelling and pressure in the orbit more rapidly. This corticosteroid works differently from antibiotics by targeting inflammation directly, potentially leading to quicker symptom relief. Additionally, its administration via intravenous injection ensures fast delivery to the affected area, which might enhance its effectiveness in acute situations.
What evidence suggests that dexamethasone might be an effective treatment for orbital cellulitis?
This trial will compare the effects of dexamethasone and a placebo in treating orbital cellulitis. Research has shown that dexamethasone, a type of medicine, might reduce swelling and inflammation in serious eye infections by decreasing inflammation around the eye. However, results from studies are mixed. Some studies have not demonstrated clear benefits for children with eye infections when using steroids like dexamethasone. Evidence also suggests that dexamethasone might improve quality of life and reduce the need for additional treatments in other types of infections. While there is potential, more research is needed to confirm its effectiveness specifically for eye infections.12467
Are You a Good Fit for This Trial?
This trial is for children and youth aged 2 months to under 18 years, hospitalized with confirmed or suspected orbital cellulitis. They must be admitted for less than 36 hours, have not received recent corticosteroids treatment, and cannot have been exposed to varicella or had a recent hospital admission for the same condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IV dexamethasone 0.3 mg/kg or placebo, with two doses administered 24 hours apart
Follow-up
Participants are monitored for safety and effectiveness after treatment, including intervention fidelity and completion of trial outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
Trial Overview
The study compares Dexamethasone (0.3mg/kg) with a placebo in treating orbital cellulitis in young patients. It's a pilot randomized controlled trial aiming to check feasibility for a larger future trial by assessing patient recruitment, intervention administration, and data collection.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Dexamethasone 0.3 mg/kg (max dose 12 mg) IV after randomization, and a second dose 24 hours (+/-8 hours) after the first dose
Sodium Chloride 0.9% IV after randomization and second dose 24 hours (+/- 8 hours) after the first dose
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Hospital for Sick Children
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Citations
Association of systemic corticosteroids and clinical ...
Corticosteroids may improve outcomes in severe orbital infections by reducing inflammation and oedema within the enclosed bony orbit, thereby ...
2.
publications.aap.org
publications.aap.org/hospitalpediatrics/article/12/1/70/183796/Association-Between-Corticosteroids-and-OutcomesAssociation Between Corticosteroids and Outcomes in ...
Early use of systemic corticosteroids in hospitalized children with orbital cellulitis is not associated with improved clinical outcomes. Use ...
Corticosteroids for periorbital and orbital cellulitis
We aimed to find out if steroids are useful in treating serious infections of the area around the eye known as periorbital and orbital cellulitis.
The DEXACELL trial—a protocol for a pragmatic, ...
This trial aims to determine if adjunctive oral dexamethasone can reduce pain and improve outcomes in adults with cellulitis presenting to UK urgent secondary ...
Dexamethasone versus placebo for patients with cellulitis
1. Improves quality of life and other patient-reported outcomes · 2. Reduces subsequent antimicrobial prescribing, analgesia usage and healthcare utilisation · 3.
Adjunct steroid treatment may hasten recovery in pediatric ...
However, this article and other literature do show that steroid use in cases of pediatric orbital cellulitis appears safe and likely reduces ...
Association of systemic corticosteroids and clinical ...
Objectives: To evaluate the association between corticosteroid use and clinical outcomes in children hospitalised with severe orbital infections ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.