The Effect of Postoperative Eustachian Milking Maneuver on Eustachian Tube Dysfunction

April 16, 2025 updated by: Karaman Training and Research Hospital

Eustachian Dysfunction Occurring After Adenoidectomy and/or Adenotonsillectomy and the Effect of Postoperative Eustachian Milking Maneuver on Eustachian Dysfunction

This study will evaluate the effectiveness of this lymphatic drainage method in eliminating otalgia interruption due to eustachian dysfunction and reducing middle ear pressure, which occurs in the postoperative period after adenoidectomy and/or adenotonsillectomy.

Study Overview

Detailed Description

The eustachian tube lies between the middle ear and the nasopharyngeal cavity and provides ventilation of the middle ear. The most important function of the Eustachian tube is to balance the air pressure in the middle ear with atmospheric pressure.

Temporary eustachian dysfunction and ear fullness occur in the early postoperative period after adenoidectomy and/or adenotonsillectomy. This temporary eustachian dysfunction is considered to be caused by clots and edema in the nasopharynx after surgery. In addition, trauma to the eustachian tube during adenoidectomy performed by curettage also contributes.

Eustachian dysfunction may present at the post-operative period resulted in otalgia related to middle ear pressure in the pediatric patients undergoing adenoidectomy or adenotonsillectomy. In this case, the need for analgesic agents rises in the early postoperative operiod and beyond this stituation impairs the quality of the healing process.

Reducing middle ear pressure by ensuring the mobility of the eustachian tube with the eustachian milking maneuver, which is a lymphatic drainage method, may reduce the otalgia symptoms during the post-operative recovery period, thus reducing the use of analgesic agents and improving the quality of the healing process. The aim of this observational study is to investigate to what extent a eustachian therapy maneuver corrects the negative values in middle ear pressure in the postoperative period.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Karaman, Turkey
        • Karaman Training and Research Hospital, Karaman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

80 patients aged 3-15 years who were indicated for adenoidectomy and/or adenotonsillectomy.

Description

Inclusion Criteria:

Patients with ASA 1 and 2 The parent will be able to perform eustachian milking manoeuvres

Exclusion Criteria:

Tympanometric examination performed in the preoperative period revealed eustachian dysfunction Craniofacial malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Grup 1
The children undergoing adenoidectomy and/or adenotonsillectomy whose parents will apply eustachian milking maneuver in the post-operative period.
Eustachian milking maneuver will be applied by the patients parents 3 times a day for 7 days in the post-operative period.
The children adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian healing maneuvers in the post-operative period.
Grup 2
The children undergoing adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian milking maneuvers in the post-operative period.
The children adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian healing maneuvers in the post-operative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Middle ear pressure
Time Frame: Perioperative period
Tympanometry is an objective test of middle-ear function. The test is performed by inserting the tympanometer probe in the ear canal. The instrument changes the pressure in the ear, generates a pure tone, and measures the eardrum responses to the sound at different pressures. This produces a series of data measuring how admittance varies with pressure, which is plotted as a tympanogram
Perioperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of postoperative otalgia symptoms
Time Frame: Postoperative period
Postoperative pain related to ear will be evaluated with Visual Analog Scale (VAS). Children will be asked to choose the pain they feel according to the facial expression in the picture. 0 indicates no pain, 10 indicates severe pain.
Postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ayşe Duran, MD, Karaman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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