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. 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.