An Approach to Reduce Uvula Edema After Tonsillectomy

A prospective randomized clinical trial that included thirty subjects who underwent tonsillectomy. The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy. Group 2 (n:15) patients had tonsillectomy without dexamethasone injection. Patients were examined preoperatively and postoperative on the first and fifth days. In this study investigators tried an approach of dexamethasone application to reduce uvula edema after tonsillectomy.

Study Overview

• Status: Completed
• Conditions: Edema
• Intervention / Treatment: Drug: Dexamethasone

Detailed Description

Thirty patients between the ages of 18 and 48 years were enrolled in this prospective randomized clinical trial from July 2015 to July 2016. The study was carried out in a tertiary referral center in Istanbul, Turkey. Permission for the study was obtained from Bezmialem Vakif University Clinical Research Ethics Committee, on 03 June 2015, number11/18.

The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly at three points (three points on the connection of the uvula, and palatum molle) before tonsillectomy. Group 2 (n:15) patients had tonsillectomy without dexamethasone injection. All patients had the operation under general anesthesia by utilizing the same protocol. Both of the groups were not given iv/im dexamethasone perioperatively. The surgical technique for tonsillectomy was bipolar cautery dissection performed by the same surgeon. The oropharyngeal area was examined and photographed endoscopically preoperatively and postoperative on the first and fifth days. All of the participants were examined with an 8mm diameter 70º endoscope. The photographs of the oropharynx (anterior plicas, tonsils, uvula, posterior oropharynx) were taken by holding the endoscope positioned vertically to the mouth. Blinded observers made examinations of the groups at the postoperative first and fifth days and evaluated the uvula edema by using the uvula edema scale that the investigators developed.

The investigators used a scale for grading uvula edema. There is no such scale in the English literature so the investigators developed a scale for grading uvula edema. The investigators grade edema from 1 to 5 as an increase of the edema area. It is called Grade 1 if there was elongation only at the tip of the uvula. If there was edema in the body and base of the uvula, it is called Grade 2. If the uvula edema was spread over a larger area than Grade 2, and if there was involvement in the unilateral plica, it is called Grade 3. If it was spread to both pharyngeal plicas, it is called grade 4. If the uvula edema caused the complete blockage of the posterior pharyngeal tract, it is called Grade 5.

The statistical tests were conducted using the Statistical Package for the Social Sciences version 24.0 for Windows (SPSS Inc., Chicago, Illinois, USA). All quantitative variables were estimated using measures of central location (i.e., mean and median) and measures of dispersion (i.e., standard deviation [SD]). Data normality was tested using the Shapiro-Wilk tests of normality. Descriptive statistical analysis were made. Paired t test was used for comparison of intra-group quantitative data. Independent t test was used to compare groups of quantitative data.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with recurrent tonsillitis but no sleep apnea
• Subjects older than eighteen years old
• Subjects were planned to have only tonsillectomy procedure

Exclusion Criteria:

• Subjects who must have additional procedures other than tonsillectomy
• Subjects younger than eighteen years old
• Subjects that had intravenous dexamethasone administration perioperatively

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly at three points (three points on the connection of the uvula, and palatum molle) before tonsillectomy .	Drug: Dexamethasone; The patients in Group 1 were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy; Other Names: Dexasone
No Intervention: Group 2; Group 2 (n:15) patients had tonsillectomy without dexamethasone injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of local dexamethasone administration to reduce uvula edema after tonsillectomy evaluated by using the uvula edema scale	Uvula edema wase evaluated at the postoperative first and fifth days by using the uvula edema scale that the investigators developed.	Postoperative first and fifth days

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Selahattin Tugrul, Assoc. Prof., Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Edema; Dexamethasone; Tonsillectomy; Uvula; Uvula edema; Post-tonsillectomy
• Additional Relevant MeSH Terms: Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 11/18-03.06.2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No