Introduction

Acute bacterial sinusitis (ABS) is a common complication of viral upper respiratory infections in children.

Aim

To determine the effectiveness of high-dose amoxicillin/potassium clavulanate in the treatment of children diagnosed with ABS.

Patient Profile

• 58 children (1 to 10 years of age) with ABS

Method

Study Design

• Randomized, double-blind, placebo-controlled study
• Patients were randomly assigned to receive either amoxicillin (90 mg/kg) with potassium clavulanate (6.4 mg/kg) or placebo
• Patients were examined on day 14 and a symptom survey (nasal discharge, daytime cough, or both) was performed

Endpoints

• Study outcome: Patient condition was defined as cured, improved or failed according to their symptom ratings reported by parents

Results

Efficacy

• Amoxicillin/potassium clavulanate treatment cured ABS in 50% of the pediatric patients as compared to 14% with placebo (Figure 1)
• Lesser treatment failure was experienced with amoxicillin/potassium clavulanate than children receiving the placebo (14% vs. 68% patients, respectively)

Figure 1: Effect of amoxicillin/potassium clavulanate treatment on ABS patients in comparison with placebo

Conclusion

Amoxicillin/potassium clavulanate therapy significantly cured ABS with fewer treatment failures as compared to placebo, as reported by parents of pediatric patients.

Pediatr. 2009; 124: 9-15