Intratympanic steroid injection adjunct to myringotomy with ventilation tube insertion for otitis media with effusion in children with cleft palate – a matched pair randomized controlled trial

Background: To evaluate the efficacy of adjunctive intratympanic dexamethasone therapy in improving outcomes of myringotomy with ventilation tube insertion for bilateral otitis media with effusion in children with cleft palate. Methods: Children with cleft palate aged 2–12 years were recruited. Dexa...

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Main Authors: Patorn Piromchai, Jutarat Anutragulchai, Kwanchanok Yimtae, Somchai Srirompotong, Panida Thanawirattananit
Format: Article
Language:English
Published: SAGE Publishing 2025-06-01
Series:SAGE Open Medicine
Online Access:https://doi.org/10.1177/20503121251348026
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Summary:Background: To evaluate the efficacy of adjunctive intratympanic dexamethasone therapy in improving outcomes of myringotomy with ventilation tube insertion for bilateral otitis media with effusion in children with cleft palate. Methods: Children with cleft palate aged 2–12 years were recruited. Dexamethasone or placebo was administered intratympanically based on randomized allocation, with contralateral ear receiving the alternate treatment. Results: Twenty-three children with cleft palate (mean age: 33.04 ± 27.80 months) were enrolled. Baseline demographics were comparable between groups ( p  > 0.05). Both dexamethasone and placebo groups demonstrated significant hearing level improvements at 1-month follow-up ( p  < 0.001). Patients with otitis media with effusion duration ⩽ 3 months exhibited superior outcomes in the dexamethasone group (mean difference: −3.18 dB HL, 95% CI: −4.88 to −1.49, p  = 0.002). Patients with cleft palate without other anomalies demonstrated a significant improvement in the dexamethasone group (mean difference: −3.24 dB HL, 95% CI: −5.04 to −1.43, p  = 0.002). No significant differences in adverse events were observed between groups ( p  > 0.05). Conclusions: Early intratympanic dexamethasone injection adjunct to myringotomy with ventilation tube insertion is recommended for otitis media with effusion in children with cleft palate.
ISSN:2050-3121