Steroids in the Treatment of Deep Neck Space Infections

Dr. Lutfi Kirdar Kartal Training and Research Hospital32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Deep Neck Infections

Interventions

Dexamethasone (IV)DRUG

Dexamethasone 8 mg was administered intravenously as a single dose in addition to standard treatment for deep neck infection.

Normal SalineDRUG

Normal saline (2 mL) was administered intravenously as a single dose as placebo in addition to standard treatment for deep neck infection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Change in Pain Intensity Measured by Visual Analog Scale (VAS)

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.

Time frame: Baseline, 24 hours, 48 hours, and Day 7

Secondary Outcomes

Change in Maximum Interincisor Distance

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.

Time frame: Baseline, 24 hours, 48 hours, and Day 7

Change in Body Temperature

Body temperature was measured in degrees Celsius (°C). Higher values indicate higher body temperature.

Time frame: Baseline, 24 hours, and 48 hours

Time to Pain-Free Swallowing

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.

Time frame: From study intervention until pain-free swallowing, up to Day 7

Data from ClinicalTrials.gov

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