NCT03079453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

7.7 years

First QC Date

March 9, 2017

Last Update Submit

September 14, 2026

Conditions

EdemaTonsillar Surgery Complications

Keywords

DexamethasoneTonsillectomyUvulaEdemaUvula edemaPost-tonsillectomy

Outcome Measures

Primary Outcomes (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.

    Postoperative days 1 to 3

Secondary Outcomes (5)

  • Postoperative Uvula Edema Grade

    Postoperative days 1, 3, and 5

  • Postoperative Pain Score

    postoperative days 1, 3, and 5.

  • Postoperative Dysphagia Score

    postoperative days 1, 3, and 5.

  • Postoperative Speech Difficulty Score

    postoperative days 1, 3, and 5.

  • Postoperative Breathing Difficulty Score

    postoperative days 1, 3, and 5.

Study Arms (2)

Submucosal Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Saline Control

SHAM COMPARATOR

Patients in the control group received sham injections consisting of an equal volume of normal saline administered at the same anatomical sites.

Drug: Normal Saline

Interventions

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.

Submucosal Dexamethasone
Normal SalineDRUG

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

Saline Control

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Edema

Interventions

DexamethasoneSaline Solution

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Selahattin Tugrul, Prof.

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 14, 2017

Study Start

July 15, 2018

Primary Completion

April 1, 2026

Study Completion

April 10, 2026

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)