Clinical practice guideline: Tympanostomy tubes in children.
Richard M Rosenfeld, Seth R Schwartz, Melissa A Pynnonen...
https://pubmed.ncbi.nlm.nih.gov/23818543Actively Recruiting
Phase 4
Age: 6Months - 10Years
All Genders
ID03655665
Does the Use of Topical Otic Drops at Tympanostomy Tube Placement Improve Outcomes When No Middle Ear Effusion Is Present
Led by Boston Children's Hospital · Updated on 2024-07-09
125
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if using topical otic drops during and after tympanostomy tube placement surgery lowers the chances of tube blockage and ear drainage in children who do not have fluid behind their eardrum at the time of surgery. The study focuses on patients aged 6 months to 10 years undergoing this procedure without middle ear effusion. It compares the effects of using ofloxacin ear drops in one ear versus no drops in the other ear to better understand their impact on post-operative outcomes. Participants will receive three drops of ofloxacin otic solution during and after surgery, three times daily for three days, but only in one ear. The ear receiving the drops will be randomly chosen. The other ear will not receive any treatment, allowing each participant to serve as their own control. This design helps researchers directly compare the treated and untreated ears within the same patient. Throughout the study, participants will be monitored for up to 35 days after surgery. Researchers will check for tube blockage and signs of ear drainage during this period. Follow-up visits will assess these outcomes to determine if the drops affect recovery and tube function. The study is conducted by Boston Children's Hospital and aims to provide evidence about the use of topical drops in patients without middle ear fluid at surgery time.
CONDITIONS
Brief Title
Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present
Who Can Participate
Age: 6Months - 10Years
All Genders
Eligibility Criteria
You may qualify if you...
- Participant has a history of Eustachian tube dysfunction or recurrent acute otitis media requiring bilateral tympanostomy tube placement surgery
- Participant's caregiver understands and agrees to follow the study protocol
- Children aged 6 months to 10 years undergoing bilateral tympanostomy tube placement without middle ear fluid at surgery
You will not qualify if you...
- Participant is having other procedures at the time of ear tube surgery (such as adenoidectomy or airway endoscopy)
- History of conductive hearing loss based on last audiogram
- Presence of middle ear effusion in either ear on the day of surgery
- Diagnosis of craniofacial abnormalities, Trisomy 21, primary ciliary dyskinesia, or cystic fibrosis
- History of known immunodeficiency disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 days post-surgery
Participants will undergo bilateral tympanostomy tube placement surgery. One ear will receive three drops of ofloxacin otic solution intra- and post-operatively three times per day for 3 days, while the other ear will receive no intervention.
1 surgery visit and 3 days of topical drops in one ear
Follow-up
Duration - 4 weeks post-surgery
Participants are followed up to assess the presence of drainage and tube occlusion in both ears after treatment.
1 follow-up visit approximately 4 weeks after surgery
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital at Waltham
Waltham, Massachusetts, United States, 02453
Actively Recruiting
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Research Team
K
Kenneth R. Whittemore, MD, MS
B
Brian Boudreau, PA-C
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Meta-analysis of tympanostomy tube sequelae.
D J Kay, M Nelson, R M Rosenfeld
https://pubmed.ncbi.nlm.nih.gov/11283489Parent-reported otorrhea in children with tympanostomy tubes: incidence and predictors.
Thijs M A van Dongen, Geert J M G van der Heijden, Hanneke G Freling...
https://pubmed.ncbi.nlm.nih.gov/23874870Factors of the blockage of ventilation tubes in the immediate postoperative period.
Eun-ju Jeon, Yong-Soo Park, Seung-Kyun Lee...
https://pubmed.ncbi.nlm.nih.gov/17657506Avoidance of postoperative blockage of ventilation tubes.
T S Jamal
https://pubmed.ncbi.nlm.nih.gov/7543180Acute otitis media in children with tympanostomy tubes.
Jason Schmelzle, Richard V Birtwhistle, Andre K W Tan
https://pubmed.ncbi.nlm.nih.gov/18697973Risk factors associated with postoperative tympanostomy tube obstruction.
David E Conrad, Jessica R Levi, Zachary A Theroux...
https://pubmed.ncbi.nlm.nih.gov/25009981Use of prophylactic otic drops after tympanostomy tube insertion.
H H Ramadan, T Tarazi, G M Zaytoun
https://pubmed.ncbi.nlm.nih.gov/2021473Common agents used to unblock blood clots within tympanostomy tubes: an ex vivo study and review of literature.
Emily L Burke, Rohan R Walvekar, James Lin...
https://pubmed.ncbi.nlm.nih.gov/19796828Ciprofloxacin/dexamethasone drops decrease the incidence of physician and patient outcomes of otorrhea after tube placement.
William Giles, Joseph Dohar, Kenneth Iverson...
https://pubmed.ncbi.nlm.nih.gov/17316832