A pooled analysis of seven randomized crossover studies of the palatability of cefdinir oral suspension versus amoxicillin/clavulanate potassium, cefprozil, azithromycin, and amoxicillin in children aged 4 to 8 years

Clin Ther. 2005 Dec;27(12):1950-60. doi: 10.1016/j.clinthera.2005.11.017.

Abstract

Objective: This analysis of the results of 7 trials compared the taste and smell acceptability scores of cefdinir oral suspension and 4 other pediatric antibiotic oral suspensions--amoxicillin/clavulanate potassium, cefprozil, azithromycin, or generic amoxicillin--using a visual smile-face scale.

Methods: Data from 7 randomized, single-blind, cross-over trials were pooled and analyzed. In each study, children aged 4 to 8 years were asked to taste and smell 2 different antibiotic suspensions and assign preference using a visual smile-face scale. Ratings were converted to a numeric score ranging from 5 (really good) to 1 (really bad).

Results: A total of 1011 healthy subjects were randomly assigned to 1 of 2 treatment-order groups; 965 were evaluable for the taste and smell analyses. Baseline demographics of evaluable subjects were similar among test groups. Approximately even proportions of participants were female or male (50.1 % vs 49.9%), most (84.1%) were white, and slightly more participants were aged 7 or 8 years rather than younger (age 4 years, 16.0%; age 5 years, 17.4%; age 6 years, 18.7%; age 7 years, 23.2%; age 8 years, 24.8%). Of the 965 children who tasted both antibiotic suspensions and determined their preference, 798 (82.7%) rated the taste of cefdinir as really good or good (the highest possible ratings); 712 (73.8%) assigned the same ratings to amoxicillin/clavulanate potassium, cefprozil, azithromycin, or generic amoxicillin (P < or = 0.001). With regard to smell, 671 (69.5%) rated the smell of cefdinir as really good or good; 636 (65.9%) assigned these same ratings to the comparator agents (P = NS).

Conclusion: In this pooled analysis of data from 7 randomized, single-blind, crossover trials, children between the ages of 4 and 8 years preferred the taste of cefdinir oral suspension to that of other pediatric antibiotic suspensions. Based on smile-face scores, subjects found the smell of cefdinir oral suspension to be at least as good as that of the comparators.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Amoxicillin / administration & dosage
  • Amoxicillin / adverse effects
  • Amoxicillin-Potassium Clavulanate Combination / administration & dosage
  • Amoxicillin-Potassium Clavulanate Combination / adverse effects
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / adverse effects
  • Azithromycin / administration & dosage
  • Azithromycin / adverse effects
  • Cefdinir
  • Cefprozil
  • Cephalosporins / administration & dosage
  • Cephalosporins / adverse effects
  • Child
  • Child, Preschool
  • Cross-Over Studies
  • Female
  • Humans
  • Male
  • Patient Satisfaction
  • Randomized Controlled Trials as Topic
  • Single-Blind Method
  • Smell*
  • Suspensions
  • Taste*

Substances

  • Anti-Bacterial Agents
  • Cephalosporins
  • Suspensions
  • Amoxicillin-Potassium Clavulanate Combination
  • Amoxicillin
  • Azithromycin
  • Cefdinir