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Completed

NCT Number: NCT06605937

The Effect of Postoperative Eustachian Milking Maneuver on Eustachian Tube 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.

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Key information

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karaman Training and Research Hospital, Karaman

Karaman, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eustachian milking maneuver with routine postoperative treatment protocol

Other

Eustachian milking maneuver will be applied by the patients parents 3 times a day for 7 days in the post-operative period.

Routine postoperative treatment protocol

Other

The children adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian healing maneuvers in the post-operative period.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 20, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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