An Approach to Reduce Uvula Edema After Tonsillectomy
Condition: Edema
MeSH terms: Edema
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): The patients in Group 1 were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy
Other intervention name(s): Dexasone
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dexamethasone; Tonsillectomy; Uvula; Edema; Uvula edema; Post-tonsillectomy