P23 Tolerability of prednisolone and dexamethasone in children in saudi arabia and the united kingdom
Authors: Aljebab Fahad , Alanazi Mofadhi , Choonara Imti , Conroy Sharon 
Published: January 2018

Background

Corticosteroids are used to treat conditions including acute asthma and croup where they are often given in short-courses. This study evaluated the tolerability and palatability of oral prednisolone and dexamethasone in children in Saudi Arabia (SA) and the UK.

Methods

A prospective observational/interview study was performed. Palatability was evaluated by asking patient/parent’s opinions of the taste and acceptability of the medication. Children pointed at the appropriate face on a scale depicting: 1 ‘dislike very much’, 2 ‘dislike a little’, 3 ‘not sure’, 4 ‘like a little’ and 5 ‘like very much’.1 Tolerability, in particular nausea, vomiting and abdominal pain was evaluated by direct questioning of the patient/parents after each administration. Data was collected over three months in each centre. Patients aged 2–18 years treated with oral prednisolone or dexamethasone in hospital were approached to participate.

Results

In SA, 122 patients (89 asthma, 33 croup), aged 2–10 years (mean=4.3) were recruited: 52 received prednisolone base tablets; 37 prednisolone sodium phosphate syrup; 33 dexamethasone elixir. In the UK, of 133 patients (80 asthma, 53 croup) aged 2–16 years (mean=4.9): 38 received prednisolone base tablets; 42 prednisolone sodium phosphate soluble tablets; 53 dexamethasone sodium phosphate oral solution.

SA: Day 1 prednisolone base tablet palatability scores: 1 (88.5%); 2 (11.5%). Day 2 scores: 1 (64.4%); 2 (28.9%); 3 (6.7%). Day 1 prednisolone sodium phosphate solution palatability scores: 1 (48.6%); 2 (40.5%); 3 (10.8%). Day 2 scores: 1 (10.8%); 2 (67.6%); 3 (21.6%). Day 1 dexamethasone elixir palatability scores: 1 (27.3%); 2 (48.5%); 3 (24.2%).

UK: Day 1 prednisolone base tablet palatability scores: 1 (76.3%); 2 (13.1%); 3 (5.3%); 4 (5.3%). Day 2 scores: 1 (61.3%); 2 (19.4%); 3 (16.1%); 4 (3.2%). Day 1 prednisolone sodium phosphate soluble tablet palatability scores: 1 (35.7%); 2 (26.2%); 3 (23.8%); 4 (11.9%) 5 (2.4%). Day 2 scores: 1 (16.7%); 2 (58.2%); 3 (16.7%); 4 (4.2%); 5 (4.2%). Day 1 dexamethasone sodium phosphate solution palatability scores: 1 (5.7%); 2 (28.3%); 3 (37.7%); 4 (17%); 5 (11.3%).

Dexamethasone sodium phosphate solution had the highest palatability scores (P<706;0.0001). The score was lowest for prednisolone base tablets in both centres (P<0.0001).

In SA prednisolone base tablets were associated with more cases of nausea (24 vs 7) and vomiting (5 vs 0) than prednisolone sodium phosphate syrup (p=0.008 and p=0.073 respectively). In the UK vomiting occurred significantly more frequently with prednisolone base tablets (8) than prednisolone sodium phosphate soluble tablets (2) (p=0.041).

In both centres dexamethasone was associated with less side effects but with no significant difference between the formulations. Vomiting (1 vs 0), nausea (7 vs 3) and abdominal pain (10 vs 8) occurred more with dexamethasone sodium phosphate solution than dexamethasone elixir (p=1, p=0.53 and p=0.55 respectively).

Conclusions

Dexamethasone sodium phosphate solution was the most palatable preparation. Prednisolone base tablets were rated the least palatable and were also the least well tolerated. Palatability scores seemed to improve with second doses.

Reference

H. Hames H, Seabrook JA, Matsui D, Rieder MJ, Joubert GI. A palatability study of a flavoured dexamethasone preparation versus prednisolone liquid in children. Can. J. Clin. PharmacolJanuary 2008;15(1):e95–8.