Otiprio Versus Ciprodex Tympanostomy Tube Outcomes
Otorrhea, Otitis Media With Effusion in Children
About this trial
This is an interventional treatment trial for Otorrhea focused on measuring Tympanostomy tube placement, Otiprio, Ciprodex drops, Ear drops, Middle ear
Eligibility Criteria
Inclusion Criteria:
- Children (6 months to 10 years)
- Clinical diagnosis of bilateral middle ear effusion or recurrent acute otitis media requiring tympanostomy tube placement
Exclusion Criteria:
- Patient having any other concurrent surgery
- History of mastoid surgery, chronic or recurrent bacterial infections
- Tympanic membrane perforations
- History of immunodeficiency disease
- Abnormalities of the tympanic membrane or middle ear
- Otic or systemic corticosteroid within 7 days of surgery
- Topical or systemic antimicrobials or antifungal agents prior to their particular washout intervals
- Concurrent use of anti-inflammatory agents
- Allergy to the medications used in this study and their components
- Menarcheal or postmenarcheal female.
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Otiprio by surgeon
Ciprodex by surgeon
Ciprodex by surgeon and parent
Otiprio will be administered through the tympanic membrane by the otolaryngologist immediately after tympanostomy placement.
Ciprodex drops will be instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery.
Ciprodex drops will be instilled by the otolaryngologist into the ear immediately after tympanostomy tube surgery. The parent or guardian will administer Ciprodex drops into the ears twice daily for five days after surgery.