An observational study in Postoperative Middle Ear Pressure and Otalgia, sponsored by Karaman Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 3 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Karaman Training and Research Hospital · Observational
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.
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.
Karaman Training and Research Hospital is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
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80 patients aged 3-15 years who were indicated for adenoidectomy and/or adenotonsillectomy.
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
The children undergoing adenoidectomy and/or adenotonsillectomy whose parents will apply eustachian milking maneuver in the post-operative period.
Other: Eustachian milking maneuver with routine postoperative treatment protocol · Other: Routine postoperative treatment protocol
The children undergoing adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian milking maneuvers in the post-operative period.
Other: Routine postoperative treatment protocol
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.
Middle ear pressure
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
Time frame: Perioperative period
Evaluation of postoperative otalgia symptoms
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.
Time frame: Postoperative period
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Earache
Karaman Training and Research Hospital