CClinicalTrials.gg
CompletedNCT07815028Updated Sep 11, 2026

Steroids in the Treatment of Deep Neck Space Infections

An interventional study of Dexamethasone (IV) and Normal Saline in Deep Neck Infections, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Deep Neck Infections

Keywords

  • dexamethasone
  • deep neck space infection
  • corticosteroid
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    dexamethasone group

    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 comparator
    placebo group

    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

  • DrugDexamethasone (IV)

    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.

05

What researchers measure

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.

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

06

Study locations

1 site
  • Kartal Dr. Lutfi Kirdar City Hospital
    Istanbul, Istanbul 34865, Turkey (Türkiye)
07

References and documents

Publications

  • 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. PubMed 36577172 ↗
  • 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. PubMed 31762293 ↗
  • 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. PubMed 23794382 ↗

Individual participant data

Plan to share: No — Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations. Aggregated study results will be reported in the planned publication.

08

Registry details

Key details

Study ID
NCT07815028
Lead sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible party
Gülşah Acar Yüceant (otolaryngologist, Dr. Lutfi Kirdar Kartal Training and Research Hospital) — Principal investigator
First posted
Sep 11, 2026
Start date
Mar 26, 2025
Primary completion
Jun 5, 2026
Completion
Jun 5, 2026
Last update
Sep 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion