Effectiveness of erdosteine, a second generation mucolytic agent, in children with acute rhinosinusitis: a randomized, placebo controlled, double-blinded clinical study.

AIM: To evaluate whether mucolytic agents have an adjuvant role with antibiotics in the treatment of children with rhinosinusitis. METHODS: Ninety-two children with rhinosinusitis were recruited for this randomized, placebo controlled, double-blinded clinical trial. Mean age was 8.5 +/- 3.2 years. Erdosteine (5-8 mg/kg/day) was administered to 49 children, and 43 children received placebo. Changes in symptoms were recorded with the standard S5 scoring for 14 days. Complete resolution of symptoms on day 14 was considered to be clinical improvement. RESULTS: Eighty-one participants completed the study. Forty-one were in the treatment group and 40 in the placebo group. The average S5 scoring value at the onset of study was 11.0 in treatment group and 12.1 in placebo group. On day 14, mean scores were 3.1 in the treatment group and 2.8 in the placebo group. Complete improvement was 78% in the treatment group and 74.4% in the placebo group. There was no significant difference between the groups. There were no clinically detected serious side effects or complications in both groups. CONCLUSION: Use of erdosteine as a mucolytic agent in children with acute rhinosinusitis does not directly affect the success of treatment.