Steroids in the Treatment of Deep Neck Space Infections

NCT07815028 | Completed

• 1 other identifier: 21.03.2025-37056
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Neck Infections

Keywords

dexamethasone; deep neck space infection; corticosteroid

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 24 hours, 48 hours, and Day 7

Secondary Outcomes (3)

• Change in Maximum Interincisor Distance

  Baseline, 24 hours, 48 hours, and Day 7

• Change in Body Temperature

  Baseline, 24 hours, and 48 hours

• Time to Pain-Free Swallowing

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

Study Arms (2)

dexamethasone group

EXPERIMENTAL

Participants in this arm received a single intravenous dose of 8 mg dexamethasone in addition to standard treatment for deep neck infection.

Drug: Dexamethasone (IV)

placebo group

PLACEBO COMPARATOR

Participants in this arm received 2 mL of intravenous normal saline as placebo in addition to standard treatment for deep neck infection.

Drug: Normal Saline

Interventions

Dexamethasone (IV) DRUG

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

dexamethasone group

Normal Saline DRUG

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

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Istanbul, 34865, Turkey (Türkiye)

Location

Related Publications (3)

• Konishi T, Sakata A, Inokuchi H, Kumazawa R, Matsui H, Fushimi K, Tanabe M, Seto Y, Yasunaga H. Treatments and outcomes of adult parapharyngeal and retropharyngeal abscess: 1882 cases from a Japanese nationwide database. Am J Otolaryngol. 2023 Mar-Apr;44(2):103770. doi: 10.1016/j.amjoto.2022.103770. Epub 2022 Dec 26.

  PMID: 36577172 BACKGROUND

• Tansey JB, Hamblin J, Mamidala M, Thompson J, Mclevy J, Wood J, Sheyn A. Dexamethasone Use in the Treatment of Pediatric Deep Neck Space Infections. Ann Otol Rhinol Laryngol. 2020 Apr;129(4):376-379. doi: 10.1177/0003489419890349. Epub 2019 Nov 24.

  PMID: 31762293 BACKGROUND

• Chau JK, Seikaly HR, Harris JR, Villa-Roel C, Brick C, Rowe BH. Corticosteroids in peritonsillar abscess treatment: a blinded placebo-controlled clinical trial. Laryngoscope. 2014 Jan;124(1):97-103. doi: 10.1002/lary.24283. Epub 2013 Jul 9.

  PMID: 23794382 BACKGROUND

MeSH Terms

Interventions

Dexamethasone; Saline Solution

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: otolaryngologist

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: March 26, 2025
• Primary Completion: June 5, 2026
• Study Completion: June 5, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)