Otitis Media With Effusion in Children Clinical Trial
Official title:
Otiprio Versus Ciprodex to Reduce Tympanostomy Tube Failure
Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops are the most effective, and whether a post-operative regimen should be used. Utilizing drops postoperatively places the onus of administration on parents who may have various difficulties in delivering the drops to their child's ears. Additionally, prescribing drops postoperatively is a health care cost. The purpose of this study is to determine if there is a difference in prevention of tympanostomy tube failure (defined as tube blockage or otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs administered once intraoperatively, and Ciprodex otic drops administered intraoperatively with a postoperative course.
Tympanostomy tube placement is indicated in children with recurrent acute otitis media or
chronic otitis media with effusion. Ear dishcarge, otorrhea, is the most common complication
following tympanostomy tube placement and occurs in up to 25% of patients. Otorrhea can lead
to tube obstruction, making the tube ineffective in ventilating the middle ear or improving
hearing. Otolaryngologists routinely administer ear drops at the time of tympanostomy tube
placement in order to prevent otorrhea and tube blockage; however, there is lack of consensus
as to which drops are the most effective and what dosing regimen should be used.
Options for prevention of otorrhea and tympanostomy tube blockage include intraoperative
single-dose application of topical drops or postoperative prolonged application of topical
drops. One issue with the prolonged application of drops after surgery is the requirement of
parents to administer the drops at home. Thus, the delivery of medication to the middle ear
is variable given the difficulty of administering ear drops to a child. Another option exists
as a one-time application at the time of surgery, but provides an extended duration of
medication in the middle ear. Otiprio is a single-dose suspension of ciprofloxacin and has
been FDA approved since February 2015 for use in pediatric patients with otitis media with
effusion who require tympanostomy tube placement. Otiprio exists as a liquid at or below room
temperature and transitions into a gel after exposure to body temperature in the middle ear.
Administrated as an injection into the middle ear at the time of tympanostomy tube placement,
Otipiro slowly releases antibiotic treatment over the course of a week, eliminating the need
for parents to administer drops.
The study is a prospective, randomized (1:1:1), single-blind, trial of three treatment groups
in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube
placement. Approximately 300 subjects will be randomized: 100 randomized to receive Otiprio
intraoperatively, 100 randomized to receive Ciprodex intraoperatively, and 100 randomized to
receive Ciprodex intraoperatively with five days of Ciprodex drops postoperatively.
All participants will undergo tympanostomy tube placement in the operating room as clinically
indicated by an Otolaryngologist. Prior to the surgery, the patient will be randomized to one
of the three trial arms. During the operation, the surgeon, who will be blinded until
completion of tube placement as to which arm the participant is randomized, will administer
Otiprio as a one-time intratympanic injection or Ciprodex, by administering 3-5 drops into
each ear canal. For the trial arm that includes a 5 day course of Ciprodex postoperatively,
the patient's parents will be instructed on how to administer the drops. As per standard of
care, all participants will be assessed at a postoperative visit 2-4 weeks post surgery. A
blinded assessor to the randomized study arm will perform otoscopy (ear exam) during that
visit to determine if there is presence of otorrhea or tympanostomy tube blockage.
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