Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children

Background: The role of topical corticosteroids in the treatment of acute sinusitis has not been established in children. Objective: An attempt was made to determine the impact of topical corticosteroids as an adjunct to antibiotic treatment in the management of childhood sinusitis. Methods: In a double-blind, placebo-controlled study. 151 children with sinusitis were recruited from a general pediatric outpatient clinic and 89 completed a 3-week trial. Treatment consisted of amoxicillin-clavulanate potassium, 40 mg/kg/d tid. combined with bid nasal spray of either budesonide, 50 mu g, to each nostril (n = 43) or placebo in = 46) for 3 weeks. Patients maintained daily symptom cards throughout the study and were examined by the same physician each week. Results: Clinical symptoms and signs decreased significantly in both treatment groups in comparison to baseline (P < .01). We detected a significant improvement in the scores of the cough and nasal discharge at the end of second week in the budesonide group when compared with placebo (P < .05). Friedman nonparametric repeated measures ANOVA test revealed a significant decrease in the total weekly scores of cough during the second week of budesonide treatment (P < .001) in contrast to continuous decline during the second and third weeks in the placebo group (P < .001 and P < .05, respectively). While the nasal discharge score decreased significantly during the second week in the budesonide group (P < .01), no significant effect on the nasal discharge score was observed in the placebo group. Conclusion: These data suggest that topical corticosteroids may be a useful ancillary treatment to antibiotics in childhood sinusitis and effective in reducing the cough and nasal discharge earlier in the course of acute sinusitis.