- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06605937
The Effect of Postoperative Eustachian Milking Maneuver on Eustachian Tube Dysfunction
Eustachian Dysfunction Occurring After Adenoidectomy and/or Adenotonsillectomy and the Effect of Postoperative Eustachian Milking Maneuver on Eustachian Dysfunction
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Karaman, Turkey
- Karaman Training and Research Hospital, Karaman
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Grup 1
The children undergoing adenoidectomy and/or adenotonsillectomy whose parents will apply eustachian milking maneuver in the post-operative period.
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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.
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Grup 2
The children undergoing adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian milking maneuvers in the post-operative period.
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The children adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian healing maneuvers in the post-operative period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Middle ear pressure
Time Frame: Perioperative period
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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
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Perioperative period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluation of postoperative otalgia symptoms
Time Frame: Postoperative period
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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.
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Postoperative period
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Collaborators and Investigators
Investigators
- Principal Investigator: Ayşe Duran, MD, Karaman Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-2024/03
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