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

The efficacy of intratympanic steroid injection adjunct to myringotomy with ventilation tube for otitis media with effusion in children : Randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200526001

Enrollment

Unknown

Registered

2020-05-26

Start date

2020-05-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

children with bilateral otitis media with effusion&#44

Interventions

intratympanic steroid injection (Dexamethasone) in one randomized ear after myringotomy.,no intervention

Experimental Drug,No Intervention No treatment

intratympanic steroid injection,à¸·no intervention

Eligibility

Sex/Gender

All

Age

2 Months to 12 Years

Inclusion criteria

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

Exclusion criteria: Mucociliary disease - Chronic medical disease à¹€à¸Šà¹ˆà¸™ diabetes mellitus - Unilateral nasal mass, unilateral nasaopharyngeal mass - allergy of steroid

Design outcomes

Primary

Measure	Time frame
Hearing level 1, 3, 6 months Audiometry	—

Secondary

Measure	Time frame
Recurrent rate 1, 3, 6 months follow up within 6 months	—

Countries

Thailand

Contacts

Public ContactJutarat Anutragulchai

Khonekaen university

jutaan@kkumail.com099-4614714

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026