Authors: Mary A. Cifaldi¹; Maria M. Paris²; Karen J. Devcich²; Stanley Bukofzer²

Source: Pediatric Drugs, Volume 6, Number 6, 2004 , pp. 387-393(7)

Publisher: Adis International

Abstract:

Objective: To compare parent-reported outcomes (satisfaction, tolerability, compliance, and work/daycare missed) for children (aged 6 months to 6 years) receiving either cefdinir or amoxicillin/clavulanate for acute otitis media.

Method: In a phase IV, investigator-blinded, parallel-group, randomized, multicenter study, parents or legal guardians were asked to complete the Otitis Parent Questionnaire (OPQ) 12–14 days after the first dose of cefdinir or amoxicillin/clavulanate oral suspensions. Responses in each of the outcome domains were analyzed using non-parametric statistical analysis.

Results: Of 367 parents/guardians who completed the questionnaire, better ease of use (p = 0.009) and taste (p < 0.0001) were associated with cefdinir versus amoxicillin/clavulanate treatment, and children were significantly more likely to experience vomiting with amoxicillin/clavulanate (16% vs 8%; p = 0.016). Parents also reported that their children were much more likely to take all of their medication if receiving cefdinir (68% vs 53% for amoxicillin/clavulanate; p = 0.005). There were no statistically significant differences between groups in work/daycare missed.

Conclusion: Based on parents’ assessment using the OPQ, cefdinir was easier to administer and tasted better than amoxicillin/clavulanate. Children who received cefdinir also experienced less vomiting and had greater compliance than children who received amoxicillin/clavulanate.

Keywords: Otitis media; Cefdinir; Amoxicillin; Clavulanic acid

Document Type: Research article

Affiliations: 1: 1 Health Economics and Outcomes Research, Abbott Laboratories, Abbott Park, Illinois, USA 2: 2 Clinical Research, Abbott Laboratories, Abbott Park, Illinois, USA

Publication date: 2004-01-01

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