TOLERABILITY OF PREDNISOLONE AND DEXAMETHASONE IN CHILDREN IN SAUDI ARABIA

Corticosteroids are used to treat a variety of medical conditions including acute asthma and croup where they are often given in short-courses. Epidemiological studies in Saudi Arabia show an increasing prevalence of respiratory diseases such as asthma in the past three decades.1 This study aimed to evaluate the tolerability and palatability of oral prednisolone and dexamethasone in children in Saudi Arabia. Both drugs are available in different formulations from different pharmaceutical companies.

Prospective observational and interview study. The palatability of the oral corticosteroids was evaluated by asking children and their parent's opinions of the taste and acceptability of the medication soon after drug administration. Children were asked to point at the appropriate face on a 10-cm visual analogue scale depicting five degrees of pleasure: 1 'dislike very much, 2 'dislike a little', 3 'not sure', 4 'like a little' and 5 'like very much'.2 The tolerability of the drugs, in particular nausea, vomiting and abdominal pain was also evaluated by direct questioning of the parent/patients after each drug administration, and at the end of the course. Data was collected over three months, February to April 2015. Patients aged 2-18 years with any condition being treated with oral prednisolone or dexamethasone in hospital were approached to participate.

122 patients (89 with asthma and 33 with croup) age range 2-11 years (mean=4.3) were recruited. 52 patients were given prednisolone base tablets, 37 patients were given prednisolone sodium phosphate syrup and 33 patients dexamethasone oral solution.The palatability score was lowest for the prednisolone base tablet (Mean rating=1.12), (prednisolone sodium phosphate group, Mean=1.62, 95% CI -0.75, -0.26; P=0.000001) (dexamethasone group, Mean=1.97, 95% CI -1.11, -0.6; P=0.000001). Dexamethasone was rated the most palatable (prednisolone sodium phosphate, 95% CI 0.08, 0.62; P=0.012). Nausea and vomiting occurred only in patients given prednisolone base tablets (24 and five patients respectively). Both were statistically more frequent when compared with the prednisolone sodium phosphate group (only four patients had nausea) (95% CI 0.19, 0.52; P=0.000001 and 95% CI 0.1, 0.18; P=0.024 respectively). In the dexamethasone group only two patients had nausea. Abdominal pain was reported in 13 patients given prednisolone sodium phosphate syrup compared to eight patients in the prednisolone tablet group (95% CI 0.02, 0.38; P=0.032). In the dexamethasone group eight patients had abdominal pain.

Dexamethasone was the most palatable preparation though it did cause abdominal pain in nearly one quarter of patients. Prednisolone base tablets were rated the least palatable preparation and were also the least well tolerated.