The efficacy of intratympanic steroid injection adjunct to myringotomy with ventilation tube for otitis media with effusion in childre

Phase 3

Recruiting

• Conditions: children with bilateral otitis media with effusion, intratympanic dexamethasone; intratympanic steroid injection, myringotomy with ventilation tube, OME

• Registration Number: TCTR20200526001
• Lead Sponsor: Khonekaen university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-26
• Study Completion: 2021-03-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

-2 month to 12 years of age
-Bilateral otitis media with effusion duration more than 3 months Hearing loss > 20 dB
- Recurrent AOM with otitis media with effusion (unilateral or bilateral otitis media with effusion)
-Otitis media with effusion in children at risk

Exclusion Criteria

Mucociliary disease - Chronic medical disease เช่น diabetes mellitus - Unilateral nasal mass, unilateral nasaopharyngeal mass - allergy of steroid

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hearing level 1, 3, 6 months Audiometry

Secondary Outcome Measures

Name	Time	Method
Recurrent rate 1, 3, 6 months follow up within 6 months