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Treatment of persistent eustachian tube dysfunction in children with aerosolized nasal dexamethasone phosphate versus
Insights
Nasal aerosolized dexamethasone showed some benefit for children with persistent eustachian tube dysfunction, improving middle ear pressure and function within two weeks. However, long-term differences were not significant, and caution is advised due to potential cortisol level changes.
Area of Science:
- Otolaryngology
- Pediatric Medicine
- Pharmacology
Background:
- Persistent eustachian tube dysfunction (ETD) affects children, potentially leading to middle ear issues.
- Current treatment options for pediatric ETD are limited, necessitating exploration of pharmacological interventions.
Purpose of the Study:
- To evaluate the efficacy and safety of aerosolized nasal dexamethasone phosphate in treating persistent eustachian tube dysfunction in children.
- To assess the impact of dexamethasone on middle ear pressure, tympanic membrane function, and plasma cortisol levels.
Main Methods:
- A randomized, placebo-controlled trial involving 45 children aged 2-10 years with persistent ETD.
- Participants received either aerosolized nasal dexamethasone or placebo for three weeks, with weekly assessments of tympanometry and otoscopy.
- Plasma cortisol levels were measured before and after the treatment period.
Main Results:
- The dexamethasone group showed significant improvements in middle ear pressure and gradient within the first two weeks compared to placebo.
- Within the dexamethasone group, statistically significant improvements were observed in middle ear pressure, tympanic membrane mobility, and position.
- No overall declining trend in plasma cortisol was noted, but two patients experienced transiently low cortisol levels.
Conclusions:
- Nasal aerosolized dexamethasone demonstrates short-term therapeutic efficacy for pediatric persistent ETD.
- The observed improvements suggest a limited therapeutic window, with most benefits occurring within the first two weeks.
- Due to potential side effects like transient cortisol suppression, dexamethasone therapy should be limited to two weeks and used cautiously.
Abstract:
Forty-five children aged two to 10 years with persistent eustachian tube dysfunction received a three-week course of aerosolized nasal dexamethasone phosphate or placebo. Patients were randomly assigned to the drug or placebo group and received one spray in each nostril three times a day for three weeks. Middle ear pressure and gradient were assessed with tympanometry. Tympanic membrane mobility, position and presence of middle ear fluid were assessed by the investigators initially and at weekly intervals during the study. Fasting morning plasma cortisol levels were obtained prior to starting the study and at its conclusion. The dexamethasone-treated group showed a significant increase in patients with normal middle ear pressure compared to placebo after one week and a significant increase in the number of patients with normal middle ear gradient at the second week. By the conclusion of the study there were no significant differences between the groups. Within the dexamethasone group, however, there were statistically significant increases in patients achieving normal middle ear pressure, tympanic membrane mobility and position in one or both ears. Plasma cortisol levels fluctuated widely from one determination to another and did not show an over-all declining trend for the dexamethasone group. However, two dexamethasone patients had a transient fall in cortisol level to below the normal range. These results support some therapeutic efficacy for nasal aerosolized dexamethasone but also point out the therapeutic value of time alone. The observation that most improvement occurred in the first two weeks and that some worrisome cortisol changes occurred suggests that dexamethasone therapy should be limited to two weeks and be undertaken with caution.