345 - Tastes great, less filling! Comparison of oral dexamethasone preparations for children with asthma and croup

Poster Number: 345
Publication Number: 345.204

Andrea Goettel, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States; Holly Hanson, Vanderbilt University School of Medicine, Nashville, TN, United States; Jennifer Overfield, Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN, United States; Clark J. Thornton, Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashvill, TN, United States; Donald H. Arnold, Vanderbilt University School of Medicine, Nashville, TN, United States

Background: Dexamethasone has been shown to be effective for croup and acute asthma exacerbations in children However, it remains unknown which oral dexamethasone preparation is most palatable and tolerable for these children.

Objective: To evaluate the palatability and tolerability of oral dexamethasone tablets crushed in apple sauce compared with the IV solution mixed with compounding syrup.

Design/Methods: We conducted a randomized control trial in children aged 1-7 years with croup or acute asthma exacerbations in a tertiary children’s hospital emergency department. After consent, participants were randomized in randomly-permuted blocks of 4 to received dexamethasone (0.6 mg/kg rounded to next whole mg, maximum 16 mg) as crushed tablets in apple sauce or as IV solution in Humco® cherry-flavored compounding syrup. At 1-hour post drug administration, the parent completed a data form that included a 10 cm, “smiley face” visual analog scale and tolerability questions. The parent was asked to mark the 10 cm scale at the point corresponding to the palatability of the drug for their child. We used the Chi-square and Wilcoxon rank-sum tests to examine univariate associations and a multiple logistic regression model with robust standard errors to compare the palatability of dexamethasone preparations while adjusting for age.

Results: Among 40 participants, 20 were randomized to each treatment-allocation arm with median [IQR] age 2.8 [1.6, 4.8] years, 52% male, 77% with acute asthma exacerbations and median dexamethasone dose 8.5 [7, 10.5] mg. Univariate comparisons between dexamethasone preparations are displayed in Table 1. Participants receiving the IV solution were younger and experienced greater palatability (Figure 1). In logistic regression, the IV preparation was more palatable (β-coefficient for visual analog scale 2.5, 95% CI 0.3, 4.7) after adjusting for age.Conclusion(s): Our findings indicate that dexamethasone IV solution in cherry compounding syrup is more palatable by 2.5 cm on a 10 cm visual analog scale in comparison with the tablet preparation in apple sauce, after adjusting for age. This is a clinically meaningful difference and may be a result of the inability of apple sauce to disguise the bitter taste of the tablet. A greater proportion experienced nausea after the tablet preparation, though our sample was underpowered to detect a statistically significant difference.
In conclusion, dexamethasone IV solution in cherry compounding syrup is more palatable in comparison with the tablet preparation in apple sauce among children with acute asthma exacerbations and croup.
Table 1. Univariate comparisons for 40 children with asthma or croup in RCT of two dexamethasone preparations
Figure 1. Palatability measured using a 10 cm visual analog scale for dexamethasone as crushed tablets in applesauce and IV solution in cherry compounding syrup. Box comprise IQR with median lines across boxes. Fences are 1.5 value of IQR beyond IQR bounds. Wilcoxon rank-sum p = 0.02.