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Submucosal Dexamethasone After Tonsillectomy

Submucosal Dexamethasone After Tonsillectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03079453
Enrollment
74
Registered
2017-03-14
Start date
2018-07-15
Completion date
2026-04-10
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema, Tonsillar Surgery Complications

Keywords

Dexamethasone, Tonsillectomy, Uvula, Edema, Uvula edema, Post-tonsillectomy

Brief 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). 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.

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.

Interventions

DRUGDexamethasone

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.

DRUGNormal Saline

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

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Uvula Edema Score from Postoperative Day 1 to Day 3Postoperative days 1 to 3The primary outcome was the change in postoperative uvula edema score between postoperative days 1 and 3.

Secondary

MeasureTime frameDescription
Postoperative Uvula Edema GradePostoperative days 1, 3, and 5Postoperative 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.
Postoperative Pain Scorepostoperative days 1, 3, and 5.Postoperative pain was assessed using a visual analog scale (VAS) on postoperative days 1, 3, and 5.
Postoperative Dysphagia Scorepostoperative days 1, 3, and 5.Postoperative dysphagia was assessed using a visual analog scale (VAS) on postoperative days 1, 3, and 5.
Postoperative Speech Difficulty Scorepostoperative days 1, 3, and 5.Postoperative speech difficulty was assessed using a visual analog scale (VAS) on postoperative days 1, 3, and 5.
Postoperative Breathing Difficulty Scorepostoperative days 1, 3, and 5.Postoperative breathing difficulty was assessed using a visual analog scale (VAS) on postoperative days 1, 3, and 5.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORSelahattin Tugrul, Prof.

Bezmialem Vakif University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026