Deep Neck Infections
Conditions
Keywords
dexamethasone, deep neck space infection, corticosteroid
Brief summary
This randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of dexamethasone as an adjunct to standard treatment in patients with deep neck infections. Participants were randomly assigned to receive either a single intravenous dose of 8 mg dexamethasone or placebo in addition to standard treatment. The study evaluated changes in pain severity, interincisor distance, and body temperature, as well as the time to pain-free swallowing. Participants were followed from baseline through Day 7.
Interventions
Dexamethasone 8 mg was administered intravenously as a single dose in addition to standard treatment for deep neck infection.
DRUGNormal Saline
Normal saline (2 mL) was administered intravenously as a single dose as placebo in addition to standard treatment for deep neck infection.
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 years or older * diagnosis of a deep neck space infection confirmed by clinical examination and contrast-enhanced computed tomography * provision of written informed consent
Exclusion criteria
* Isolated peritonsillar abscess * Age younger than 18 years * Systemic corticosteroid use before enrollment * Hospitalization for a diagnosed or suspected deep neck infection within the preceding 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline, 24 hours, 48 hours, and Day 7 | Pain intensity was assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores were recorded at baseline, 24 hours, 48 hours, and Day 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Interincisor Distance | Baseline, 24 hours, 48 hours, and Day 7 | Maximum interincisor distance was measured in millimeters (mm) as the distance between the upper and lower central incisors during maximal mouth opening. Higher values indicate greater mouth opening. |
| Change in Body Temperature | Baseline, 24 hours, and 48 hours | Body temperature was measured in degrees Celsius (°C). Higher values indicate higher body temperature. |
| Time to Pain-Free Swallowing | From study intervention until pain-free swallowing, up to Day 7 | Time from administration of the study intervention to the first time the participant reported pain-free swallowing was recorded in hours. A shorter time indicates earlier resolution of swallowing-related pain. |
Countries
Turkey (Türkiye)
Outcome results
None listed