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NCT Number: NCT03079453

Submucosal Dexamethasone After Tonsillectomy

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.

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Key information

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dexamethasone

Drug

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 saline

Drug

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

Primary outcomes

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

    Time frame: Postoperative days 1 to 3

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

Secondary outcomes

  1. Postoperative Uvula Edema Grade

    Time frame: Postoperative days 1, 3, and 5

    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.

  2. Postoperative Pain Score

    Time frame: postoperative days 1, 3, and 5.

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

  3. Postoperative Dysphagia Score

    Time frame: postoperative days 1, 3, and 5.

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

  4. Postoperative Speech Difficulty Score

    Time frame: postoperative days 1, 3, and 5.

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

  5. Postoperative Breathing Difficulty Score

    Time frame: postoperative days 1, 3, and 5.

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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2017
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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