Deep Neck InfectionsNCT07815028
Steroids in the Treatment of Deep Neck Space Infections
A study testing Dexamethasone (IV) and Normal Saline in people with Deep Neck Infections, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Neck Infections
- What is being tested?
- Dexamethasone (IV) and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lutfi Kirdar City Hospital
Istanbul, Istanbul, 34865
About this study
Official title: Efficacy and Safety of Steroids in the Treatment of Deep Neck Space Infections: A Double-Blind, Randomized, Placebo-Controlled Trial
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
- Being tested
- Dexamethasone (IV), Normal Saline
- Keywords
- dexamethasone, deep neck space infection, corticosteroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 24 hours, 48 hours, and Day 7
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From study intervention until pain-free swallowing, up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start26 Mar 2025
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep Neck InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gülşah Acar Yüceant, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815028
- Sponsor's protocol ID
- 21.03.2025-37056
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 36577172Tansey 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 31762293Chau 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Steroids in the Treatment of Deep Neck Space Infections: A Double-Blind, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07815028
- Acronym / sponsor ID
- 21.03.2025-37056
- Conditions
- Deep Neck Infections
- Keywords
- dexamethasone, deep neck space infection, corticosteroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone group | Experimental | Drug: Dexamethasone (IV)Participants in this arm received a single intravenous dose of 8 mg dexamethasone in addition to standard treatment for deep neck infection. |
| placebo group | Placebo comparator | Drug: Normal SalineParticipants in this arm received 2 mL of intravenous normal saline as placebo in addition to standard treatment for deep neck infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone (IV)Dexamethasone 8 mg was administered intravenously as a single dose in addition to standard treatment for deep neck infection. | Drug | dexamethasone group |
| Normal SalineNormal saline (2 mL) was administered intravenously as a single dose as placebo in addition to standard treatment for deep neck infection. | Drug | placebo group |
Primary outcome
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: 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.
3 secondary outcomes
Change in Maximum Interincisor Distance
Time frame: Baseline, 24 hours, 48 hours, and Day 7
Change in Body Temperature
Time frame: Baseline, 24 hours, and 48 hours
Time to Pain-Free Swallowing
Time frame: From study intervention until pain-free swallowing, up to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 36577172Konishi 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.
- Background: PubMed 31762293Tansey 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.
- Background: PubMed 23794382Chau 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone (IV) and Normal Saline in people with Deep Neck Infections, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Baseline, 24 hours, 48 hours, and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07815028, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.