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EdemaPhase 4NCT03079453

Submucosal Dexamethasone After Tonsillectomy

A Phase 4 study testing Dexamethasone and Normal Saline in people with Edema and Tonsillar Surgery Complications, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this prospective controlled study, 74 adults undergoing elective bilateral tonsillectomy for recurrent tonsillitis were consecutively enrolled and sequentially assigned in a 1:1 ratio to receive either local submucosal dexamethasone (8 mg, 1 mL; n = 37) or an equal volume of normal saline (n = 37). Read more about this study

Who is it for?
Ages 18 to 44 years
Conditions the study is for
Edema, Tonsillar Surgery Complications
What is being tested?
Dexamethasone and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jul 2018to 10 Apr 2026
Phase
Phase 4
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 to 44 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adults aged 18-44 years Scheduled for elective bilateral tonsillectomy Indication for surgery: recurrent tonsillitis

Who cannot join

  • Age <18 years Obstructive sleep apnea Concomitant surgical procedures Acute tonsillitis or peritonsillar abscess at the time of surgery Perioperative systemic corticosteroid use ASA physical status III or higher

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bezmialem Vakif University

    Istanbul, Fatih, 34093

Other trials in Turkey (Türkiye)

About this study

In this prospective controlled study, 74 adults undergoing elective bilateral tonsillectomy for recurrent tonsillitis were consecutively enrolled and sequentially assigned in a 1:1 ratio to receive either local submucosal dexamethasone (8 mg, 1 mL; n = 37) or an equal volume of normal saline (n = 37). The primary outcome was the change in postoperative uvula edema score between postoperative days 1 and 3. Secondary outcomes included postoperative uvula edema grades, pain, dysphagia, speech difficulty, and breathing discomfort assessed on postoperative days 1, 3, and 5.

Read the detailed description

Study Design This study was designed as a prospective, controlled clinical trial conducted at a tertiary referral otorhinolaryngology center. The primary objective was to evaluate whether perioperative local dexamethasone administration accelerates the resolution of uvula edema following tonsillectomy. Secondary objectives included evaluating the relationship between uvula edema severity and patient-reported functional symptoms.

The study protocol was approved by the institutional ethics committee (No. 11/18), and written informed consent was obtained from all participants. The study was conducted in accordance with the Declaration of Helsinki.

Participants Adult patients aged 18-44 years who were scheduled for elective bilateral tonsillectomy due to recurrent tonsillitis were eligible for inclusion. Patients were excluded if they were younger than 18 years; had a diagnosis of obstructive sleep apnea; were scheduled for concomitant surgical procedures; had acute tonsillitis or a peritonsillar abscess at the time of surgery; had received perioperative systemic corticosteroids; or had an American Society of Anesthesiologists (ASA) physical status of III or higher.

Patient Enrollment, Intervention, and Blinding Eligible patients were consecutively enrolled and sequentially assigned in an alternating 1:1 ratio to the dexamethasone (DEX) or control group according to the predefined study protocol. Patients in the DEX group received 8 mg (1 mL) of dexamethasone administered via submucosal injection at three predefined sites around the base of the uvula and adjacent soft palate immediately before tonsillectomy (Figure 1). Patients in the control group received sham injections consisting of an equal volume of normal saline administered at the same anatomical sites. All tonsillectomy procedures were performed under general anesthesia using the bipolar cautery dissection technique by the same two surgeons. No patient received perioperative systemic corticosteroids. Owing to the nature of the intervention, the operating surgeons were aware of group allocation. However, patients and outcome assessors were blinded to treatment assignment. Postoperative assessments were performed independently by two otolaryngologists who were not involved in the surgical procedures.

Outcome Measures The primary outcome was the change in postoperative uvula edema score between postoperative days 1 and 3. This interval was selected to capture the peak inflammatory phase of postoperative uvula edema and to evaluate the early effect of dexamethasone on edema severity.

Secondary outcomes included postoperative uvula edema grades assessed on postoperative days 1, 3, and 5; the change in uvula edema score between postoperative days 1 and 5; postoperative pain; and patient-reported functional symptoms, including dysphagia, speech difficulty, and breathing discomfort.

Outcome Assessment Postoperative uvula edema was assessed using a five-grade semiquantitative visual grading system (Grades I-V) developed by the investigators and illustrated with standardized schematic drawings and representative endoscopic photographs (Figures 2 and 3). The grading system was based on the extent of uvular enlargement and involvement of adjacent pharyngeal structures. Grade I was defined as edema confined to the tip of the uvula, whereas Grade V was defined as severe uvular edema causing complete obstruction of the posterior pharyngeal airway. Detailed grading criteria are shown in Figures 2 and 3.

Before patient assessment, outcome assessors were calibrated using the reference illustrations to ensure consistent application of the grading criteria. Because no validated grading system for postoperative uvula edema was available, this scale was developed as a pragmatic tool for comparative assessment within the present study.

Patient-reported dysphagia, speech difficulty, breathing discomfort, and postoperative pain were evaluated using separate 10-point visual analog scales (VAS), where higher scores indicated greater symptom severity. Assessments were performed on postoperative days 1, 3, and 5 concurrently with endoscopic examinations.

Standardized endoscopic photographs of the oropharynx were obtained preoperatively and on postoperative days 1, 3, and 5 using a 70° rigid endoscope under uniform lighting and positioning conditions. Images were anonymized and independently evaluated by the blinded assessors.

Postoperative Analgesic Protocol All patients received a standardized postoperative analgesic regimen consisting of oral paracetamol administered at fixed doses for five consecutive days following surgery. According to the study protocol, the use of additional or rescue analgesic medications was not permitted. Patients were instructed not to use any supplementary analgesics during the postoperative follow-up period.

Being tested
Dexamethasone, Normal Saline
Keywords
Dexamethasone, Tonsillectomy, Uvula, Edema, Uvula edema, Post-tonsillectomy
Medical subject headings
Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Dexamethasone 8 mg (1 mL) was administered by submucosal injection at three predefined sites around the base of the uvula and adjacent soft palate immediately before tonsillectomy.

  • Normal SalineDrug

    An equal volume of normal saline was administered by sham submucosal injection at the same anatomical sites immediately before tonsillectomy.

Study groups in NCT03079453
Study groupRoleWhat they receive
Submucosal DexamethasoneActive comparatorPatients in the DEX group received 8 mg (1 mL) of dexamethasone administered via submucosal injection at three predefined sites around the base of the uvula and adjacent soft palate immediately before tonsillectomy
Receives: Drug: Dexamethasone
Saline ControlSham comparatorPatients in the control group received sham injections consisting of an equal volume of normal saline administered at the same anatomical sites.
Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Uvula Edema Score from Postoperative Day 1 to Day 3

    The primary outcome was the change in postoperative uvula edema score between postoperative days 1 and 3.

    Measured: Postoperative days 1 to 3

Secondary outcomes (5)
  1. Postoperative Uvula Edema Grade

    Postoperative uvula edema was assessed using the predefined five-grade uvula edema grading scale. Uvula edema was evaluated on postoperative days 1, 3, and 5, and edema grades were compared between the dexamethasone and sham-control groups.

    Measured: Postoperative days 1, 3, and 5

  2. Postoperative Pain Score

    Postoperative pain was assessed using a visual analog scale (VAS) on postoperative days 1, 3, and 5.

    Measured: postoperative days 1, 3, and 5.

  3. Postoperative Dysphagia Score

    Postoperative dysphagia was assessed using a visual analog scale (VAS) on postoperative days 1, 3, and 5.

    Measured: postoperative days 1, 3, and 5.

  4. Postoperative Speech Difficulty Score

    Postoperative speech difficulty was assessed using a visual analog scale (VAS) on postoperative days 1, 3, and 5.

    Measured: postoperative days 1, 3, and 5.

  5. Postoperative Breathing Difficulty Score

    Postoperative breathing difficulty was assessed using a visual analog scale (VAS) on postoperative days 1, 3, and 5.

    Measured: postoperative days 1, 3, and 5.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study start15 Jul 2018
  3. Primary completion1 Apr 2026
  4. Study completion10 Apr 2026

Resources

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 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079453
Sponsor's protocol ID
11/18-03.06.2015
Status last verified
Sep 2026
First submitted
9 Mar 2017
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone and Normal Saline in people with Edema and Tonsillar Surgery Complications, run by Bezmialem Vakif University 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 1 inclusion and 1 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 16 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Uvula Edema Score from Postoperative Day 1 to Day 3 (time frame: Postoperative days 1 to 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 Sep 2026.

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