An Approach to Reduce Uvula Edema After Tonsillectomy

NCT03079453 | Completed Phase 4

• 1 other identifier: 11/18-03.06.2015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2

NO INTERVENTION

Group 2 (n:15) patients had tonsillectomy without dexamethasone injection.

Interventions

Dexamethasone DRUG

The patients in Group 1 were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy

Also known as: Dexasone

Group 1

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Edema

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Selahattin Tugrul, Assoc. Prof.

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Thirty patients ages 18 to 48 years who underwent tonsillectomy included in this prospective randomized clinical trial. 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.Blinded observers made examinations of the groups postoperative on the first and fifth days and evaluated the uvula edema by using the uvula edema scale that the investigators developed.

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 14, 2017
• Study Start: July 15, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 10, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)