Background: Oral corticosteroids are an essential part of the management of children with acute asthma exacerbations. Vomiting is a frequently cited problem attributed to oral corticosteroids. A new formulation of prednisolone, Orapred, claims to have improved palatability that may decrease the incidence of vomiting.
Objective: To compare the incidence of vomiting and taste between patients who are given the generic preparation of prednisolone with those given Orapred.
Design/Methods: A randomized, double blind clinical trial was conducted at a tertiary care children s hospital emergency department. Children age 2 to 10 years presenting with acute asthma exacerbation were eligible. Patients with allergy to prednisolone, corticosteroid use within 2 weeks, history of vomiting in the last 24 hours, requirement for vascular access, and preference for other forms of corticosteroid were excluded. Enrolled patients were randomized and given either generic prednisolone (15 mg/5 ml) or Orapred (15 mg/5 ml). In children 6 years or older, a taste score was obtained using a 5 point hedonic face scale (1 = bad to 5 = great). After the administration, patients were observed for 30 minutes for vomiting. The Mann-Whitney U test was used to compare the median taste score between the two study groups. Relative risk (RR) of vomiting was calculated. Other confidence intervals were calculated when appropriate.
Results: During the study period, 211 eligible children were enrolled, of whom 23 were excluded. Of the remaining 188 subjects, 96 received generic prednisolone and 92 received Orapred. All baseline characteristics were similar in both groups. In the generic prednisolone group, 17 (17.7%) children vomited compared with 5 (5.4%) in the Orapred group (RR = 3.26, 95% CI, 1.25, 8.47). Taste scores were obtained from 18 children in the generic prednisolone group and from 19 children in the Orapred group. The median taste score was 2 for the generic prednisolone group and 4 for the Orapred group (Δ = -2.0, 95% CI, -3.0, -1.0) (P = 0.0001).
Conclusions: In our study population, Orapred was associated with a significant less incidence of vomiting and better taste score compared to the generic prednisolone.