PEDIATRICS Vol. 107 No. 4 April 2001, pp. 619-625

A Randomized, Placebo-Controlled Trial of Antimicrobial Treatment for Children With Clinically Diagnosed Acute Sinusitis

Received May 10, 2000; accepted Sep 7, 2000.

Jane M. Garbutt^*, Marion Goldstein^*, Elliot Gellman, William Shannon^*, and Benjamin Littenberg^§

From the ^* Division of General Medical Sciences, and  Department of Pediatrics, Washington University School of Medicine, St Louis, Missouri; and the ^§ Department of Medicine, University of Vermont, Burlington, Vermont.

Objective.  Although antimicrobial treatment for children with acute sinusitis is used commonly, it is unclear whether it offers significant clinical benefit. The purpose of this study was to evaluate the effectiveness of antimicrobial treatments for acute sinusitis as they are used in community pediatric practice.

Methods.  We conducted a randomized, placebo-controlled trial in 3 community pediatric practices in St Louis, Missouri. A total of 188 patients who were between the ages of 1 and 18 years and who had had 10 to 28 days of persistent sinus symptoms and a clinical diagnosis of acute sinusitis were randomized to receive 14 days of amoxicillin (40 mg/kg/d in 3 daily doses), amoxicillin-clavulanate (amoxicillin 45 mg/kg/d in 2 daily doses), or placebo. Change in sinus symptoms was assessed both by a quantitative symptom score (the S5 score) and subjectively by the parent. Secondary outcomes included adverse effects of treatment and recurrence or relapse of sinus symptoms. Outcomes were assessed by telephone interviews over a 2-month period.

Results.  Of the 161 patients who were included in the analysis, 58 received amoxicillin, 48 received amoxicillin-clavulanate, and 55 received placebo. Day 14 improvement rates were 79%, 81%, and 79%, respectively. There were no differences in the 14-day change in S5 score among treatment groups. The rates of adverse events (amoxicillin, 19%; amoxicillin-clavulanate, 11%; placebo, 10%), relapse (amoxicillin, 12%; amoxicillin-clavulanate, 13%; placebo, 13%), and recurrence (amoxicillin, 9%; amoxicillin-clavulanate, 13%; placebo, 13%) of sinus symptoms were similar among treatment groups.

Conclusion.  Neither amoxicillin nor amoxicillin-clavulanate offered any clinical benefit compared with placebo for children with clinically diagnosed acute sinusitis.  Key words:  acute sinusitis, antimicrobial treatment, randomized controlled trial, pediatric.

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