otorrhea (ear discharge or pus) from tympanostomy tubes following myringotomy with tympanostomy tube insertion in pediatric patients who undergo the procedure for otitis media with effusion otorrhea from tympanostomy tubes, tympanostomy tube otorrhea, otitis media with effusion
Conditions
Interventions
a single intraoperative instillation of antibiotic eardrops immediately after surgery ,a single intraoperative instillation of antibiotic eardrops immediately after surgery and daily instillation of a
Experimental Drug,Experimental Drug
a single intraoperative instillation of antibiotic eardrops immediately after surgery,daily instillation of antibiotic eardrops for 5 days post-surgery.
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
No minimum to 12 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged birth to 12 years undergoing myringotomy with tympanostomy tube insertion due to otitis media with effusion, as indicated by the American Academy of Otolaryngology Head and Neck Surgery (AAO) clinical practice guidelines. This procedure is considered standard care.
Exclusion criteria
Exclusion criteria: 1.History of allergy to quinolone antibiotics. 2.Inability to attend post-operative follow-up appointments as required by the study protocol. 3.Received oral or topical antibiotic medication (other than that specified by the study) within 7 days both before and after surgery. 4.Parents/guardians are unable to administer eardrops consistently for the full 5 days as prescribed by the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of otorrhea (ear discharge or pus) from tympanostomy tubes over 12 weeks following myringotomy with tympanostomy tube insertion in pediatric patients who undergo the procedure for otitis media with effusion. Compare the incidence of otorrhea between group | — |
Secondary
| Measure | Time frame |
|---|---|
| factors associated with the development of otorrhea from tympanostomy tubes. over 12 weeks following myringotomy with tympanostomy tube insertion in pediatric patients who undergo the procedure for otitis media with effusion. number and percentage,the causative pathogens of otorrhea from tympanostomy tubes. over 12 weeks following myringotomy with tympanostomy tube insertion in pediatric patients who undergo the procedure for otitis media with effusion. number and percentage | — |
Countries
Thailand
Contacts
Public ContactKitirat Ungkanont
Faculty of Medicine, Siriraj Hospital, Mahidol University, Thailand
Outcome results
None listed