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Sharon Conroy - One of the best experts on this subject based on the ideXlab platform.

  • P23 Tolerability of Prednisolone and dexamethasone in children in saudi arabia and the united kingdom
    Archives of Disease in Childhood, 2018
    Co-Authors: Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
    Abstract:

    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 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.

  • Observational study on the palatability and tolerability of oral Prednisolone and oral dexamethasone in children in Saudi Arabia and the UK
    Archives of disease in childhood, 2017
    Co-Authors: Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
    Abstract:

    Background: Short-course oral corticosteroids are routinely used to treat acute asthma and croup. We evaluated their tolerability and palatability in Saudi Arabian (SA) and UK children. Methods: Prospective observational/interview study (three months in each country). Palatability was evaluated using a five-point facial scale and tolerability by direct questioning of patient/parents. Results: In SA, of 122 patients (2–10years) recruited: 52 received Prednisolone base tablets; 37 Prednisolone Sodium Phosphate syrup; 33 dexamethasone elixir. In the UK, of 133 patients (2–16years): 38 received Prednisolone base tablets (mainly crushed and dispersed); 42 Prednisolone Sodium Phosphate soluble tablets; 53 dexamethasone Sodium Phosphate oral solution. In both countries dexamethasone had the highest palatability scores (SA mean: 1.97; UK mean: 3) and Prednisolone base tablets the lowest (SA mean: 1.12; UK mean: 1.39). Palatability scores improved for all formulations of Prednisolone with each subsequent daily dose. In SA Prednisolone base tablets were associated with more nausea (24 vs 7 patients) and vomiting (5 vs 0) than Sodium Phosphate syrup (P=0.008 and P=0.073 respectively). In the UK vomiting occurred more frequently with Prednisolone base (8) than Sodium Phosphate soluble tablets (2) (P=0.041). In both centres dexamethasone was associated with less side effects. Vomiting (1 vs 0 patients), nausea (7 vs 3) and abdominal pain (10 vs 8) occurred more with dexamethasone Sodium Phosphate solution than dexamethasone elixir. Conclusions: Dexamethasone Sodium Phosphate solution was the most palatable preparation. Prednisolone base tablets were rated least palatable and were least well tolerated. Palatability scores improved with each dose taken.

  • TOLERABILITY OF Prednisolone AND DEXAMETHASONE IN CHILDREN IN SAUDI ARABIA
    Archives of disease in childhood, 2016
    Co-Authors: Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
    Abstract:

    Background 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. Methods Prospective observational and interview study. The palatability of the oral corticosteroids was evaluated by asking children and their parent9s 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. Results 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. Conclusions 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.

  • LONG-COURSE ORAL CORTICOSTEROID TOXICITY IN CHILDREN.
    Archives of disease in childhood, 2016
    Co-Authors: Fahad Aljebab, Imti Choonara, Sharon Conroy
    Abstract:

    Background Multiple studies have evaluated and reported adverse drug reactions (ADRs) of corticosteroids. Short course oral corticosteroids are commonly used in children in the management of conditions such as asthma exacerbations. This systematic review aimed to identify the most common and serious ADRs associated with short courses of oral corticosteroids and to determine their relative risk levels in children. Methods A literature search of several databases; Embase, Medline, International Pharmaceutical Abstracts, CINAHL, the Cochrane Library and PubMed was performed to identify all studies where corticosteroids had been administered to paediatric patients ranging from 28 days to 18 years of age for up to and including 14 days of treatment. Each database was searched from their earliest dates to December 2013. All types of studies that provided clear information on adverse events were included with no language restrictions. Quality assessments were performed on all studies by two independent reviewers. Results Thirty eight studies met the inclusion criteria. These studies represented 3202 children and contained reports of 847 adverse events. The three most frequent ADRs were vomiting, increased blood pressure and behavioural changes. The incidence rates of these three ADRs were 6.3%, 8.5% and 4.8%, of patients respectively. The risk of vomiting was greater with oral Prednisolone than oral dexamethasone with a relative risk of 3.62 (95% CI 1.89, 6.95; P=0.0001, I 2 =30%). Prednisolone Sodium Phosphate was reported to cause vomiting less frequently than other Prednisolone dosage forms (P=0.047). HPA axis suppression was detected in 43 of 53 patients who were tested. The relative risk of oral Prednisolone to cause HPA axis suppression compared with inhaled steroids was 9.95 (95% CI 1.73, 53.03; P=0.010, I 2 =54%). Increased susceptibility to infection was one of the most serious ADRs, one child died after contracting a varicella zoster infection. Conclusions Vomiting, increased blood pressure and behavioural changes were the most frequent ADRs seen when short-course oral corticosteroids were given to children. In addition, increased susceptibility to infection was the most serious ADR. The majority of children who received short course oral corticosteroids will experience HPA axis suppression.

  • SHORT-COURSE ORAL CORTICOSTEROID TOXICITY IN CHILDREN
    Archives of Disease in Childhood, 2015
    Co-Authors: Fahad Ajebab, Imti Choonara, Sharon Conroy
    Abstract:

    BackgroundMultiple studies have evaluated and reported adverse drug reactions (ADRs) of corticosteroids. Short course oral corticosteroids are commonly used in children in the management of conditions such as asthma exacerbations. This systematic review aimed to identify the most common and serious ADRs associated with short courses of oral corticosteroids and to determine their relative risk levels in children.MethodsA literature search of the databases: Embase, Medline, International Pharmaceutical Abstracts, CINAHL, the Cochrane Library and PubMed was performed to identify all studies where corticosteroids had been administered to paediatric patients ranging from 28 days to 18 years of age for up to and including 14 days of treatment. Each database was searched from their earliest dates to December 2013. All types of studies that provided clear information on adverse events were included with no language restrictions. Quality assessments were performed on all studies by two independent reviewers.ResultsThirty eight studies met the inclusion criteria. These studies represented 3202 children and contained reports of 847 adverse events. The three most frequent ADRs were vomiting, increased blood pressure and behavioural changes. The incidence rates of these three ADRs were 6.3%, 8.5% and 4.8% of patients respectively. The risk of vomiting was greater with oral Prednisolone than oral dexamethasone with a relative risk of 3.62 (95% CI 1.89, 6.95; P=0.0001). Prednisolone Sodium Phosphate was reported to cause vomiting less frequently than other Prednisolone dosage forms (P=0.047). HPA axis suppression was detected in 43 of 53 patients who were tested. The relative risk of oral Prednisolone to cause HPA axis suppression compared with inhaled steroids was 9.95 (95% CI 1.73, 53.03; P=0.010). Infection was one of the most serious ADRs, one child died after contracting a varicella zoster infection.ConclusionsVomiting, increased blood pressure and behavioural changes were the most frequent ADRs seen when short-course oral corticosteroids were given to children. In addition, infection was the most serious ADR. The majority of children who receive short course oral corticosteroids will experience HPA axis suppression.

Fahad Aljebab - One of the best experts on this subject based on the ideXlab platform.

  • P23 Tolerability of Prednisolone and dexamethasone in children in saudi arabia and the united kingdom
    Archives of Disease in Childhood, 2018
    Co-Authors: Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
    Abstract:

    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 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.

  • Observational study on the palatability and tolerability of oral Prednisolone and oral dexamethasone in children in Saudi Arabia and the UK
    Archives of disease in childhood, 2017
    Co-Authors: Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
    Abstract:

    Background: Short-course oral corticosteroids are routinely used to treat acute asthma and croup. We evaluated their tolerability and palatability in Saudi Arabian (SA) and UK children. Methods: Prospective observational/interview study (three months in each country). Palatability was evaluated using a five-point facial scale and tolerability by direct questioning of patient/parents. Results: In SA, of 122 patients (2–10years) recruited: 52 received Prednisolone base tablets; 37 Prednisolone Sodium Phosphate syrup; 33 dexamethasone elixir. In the UK, of 133 patients (2–16years): 38 received Prednisolone base tablets (mainly crushed and dispersed); 42 Prednisolone Sodium Phosphate soluble tablets; 53 dexamethasone Sodium Phosphate oral solution. In both countries dexamethasone had the highest palatability scores (SA mean: 1.97; UK mean: 3) and Prednisolone base tablets the lowest (SA mean: 1.12; UK mean: 1.39). Palatability scores improved for all formulations of Prednisolone with each subsequent daily dose. In SA Prednisolone base tablets were associated with more nausea (24 vs 7 patients) and vomiting (5 vs 0) than Sodium Phosphate syrup (P=0.008 and P=0.073 respectively). In the UK vomiting occurred more frequently with Prednisolone base (8) than Sodium Phosphate soluble tablets (2) (P=0.041). In both centres dexamethasone was associated with less side effects. Vomiting (1 vs 0 patients), nausea (7 vs 3) and abdominal pain (10 vs 8) occurred more with dexamethasone Sodium Phosphate solution than dexamethasone elixir. Conclusions: Dexamethasone Sodium Phosphate solution was the most palatable preparation. Prednisolone base tablets were rated least palatable and were least well tolerated. Palatability scores improved with each dose taken.

  • TOLERABILITY OF Prednisolone AND DEXAMETHASONE IN CHILDREN IN SAUDI ARABIA
    Archives of disease in childhood, 2016
    Co-Authors: Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
    Abstract:

    Background 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. Methods Prospective observational and interview study. The palatability of the oral corticosteroids was evaluated by asking children and their parent9s 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. Results 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. Conclusions 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.

  • LONG-COURSE ORAL CORTICOSTEROID TOXICITY IN CHILDREN.
    Archives of disease in childhood, 2016
    Co-Authors: Fahad Aljebab, Imti Choonara, Sharon Conroy
    Abstract:

    Background Multiple studies have evaluated and reported adverse drug reactions (ADRs) of corticosteroids. Short course oral corticosteroids are commonly used in children in the management of conditions such as asthma exacerbations. This systematic review aimed to identify the most common and serious ADRs associated with short courses of oral corticosteroids and to determine their relative risk levels in children. Methods A literature search of several databases; Embase, Medline, International Pharmaceutical Abstracts, CINAHL, the Cochrane Library and PubMed was performed to identify all studies where corticosteroids had been administered to paediatric patients ranging from 28 days to 18 years of age for up to and including 14 days of treatment. Each database was searched from their earliest dates to December 2013. All types of studies that provided clear information on adverse events were included with no language restrictions. Quality assessments were performed on all studies by two independent reviewers. Results Thirty eight studies met the inclusion criteria. These studies represented 3202 children and contained reports of 847 adverse events. The three most frequent ADRs were vomiting, increased blood pressure and behavioural changes. The incidence rates of these three ADRs were 6.3%, 8.5% and 4.8%, of patients respectively. The risk of vomiting was greater with oral Prednisolone than oral dexamethasone with a relative risk of 3.62 (95% CI 1.89, 6.95; P=0.0001, I 2 =30%). Prednisolone Sodium Phosphate was reported to cause vomiting less frequently than other Prednisolone dosage forms (P=0.047). HPA axis suppression was detected in 43 of 53 patients who were tested. The relative risk of oral Prednisolone to cause HPA axis suppression compared with inhaled steroids was 9.95 (95% CI 1.73, 53.03; P=0.010, I 2 =54%). Increased susceptibility to infection was one of the most serious ADRs, one child died after contracting a varicella zoster infection. Conclusions Vomiting, increased blood pressure and behavioural changes were the most frequent ADRs seen when short-course oral corticosteroids were given to children. In addition, increased susceptibility to infection was the most serious ADR. The majority of children who received short course oral corticosteroids will experience HPA axis suppression.

Imti Choonara - One of the best experts on this subject based on the ideXlab platform.

  • P23 Tolerability of Prednisolone and dexamethasone in children in saudi arabia and the united kingdom
    Archives of Disease in Childhood, 2018
    Co-Authors: Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
    Abstract:

    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 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.

  • Observational study on the palatability and tolerability of oral Prednisolone and oral dexamethasone in children in Saudi Arabia and the UK
    Archives of disease in childhood, 2017
    Co-Authors: Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
    Abstract:

    Background: Short-course oral corticosteroids are routinely used to treat acute asthma and croup. We evaluated their tolerability and palatability in Saudi Arabian (SA) and UK children. Methods: Prospective observational/interview study (three months in each country). Palatability was evaluated using a five-point facial scale and tolerability by direct questioning of patient/parents. Results: In SA, of 122 patients (2–10years) recruited: 52 received Prednisolone base tablets; 37 Prednisolone Sodium Phosphate syrup; 33 dexamethasone elixir. In the UK, of 133 patients (2–16years): 38 received Prednisolone base tablets (mainly crushed and dispersed); 42 Prednisolone Sodium Phosphate soluble tablets; 53 dexamethasone Sodium Phosphate oral solution. In both countries dexamethasone had the highest palatability scores (SA mean: 1.97; UK mean: 3) and Prednisolone base tablets the lowest (SA mean: 1.12; UK mean: 1.39). Palatability scores improved for all formulations of Prednisolone with each subsequent daily dose. In SA Prednisolone base tablets were associated with more nausea (24 vs 7 patients) and vomiting (5 vs 0) than Sodium Phosphate syrup (P=0.008 and P=0.073 respectively). In the UK vomiting occurred more frequently with Prednisolone base (8) than Sodium Phosphate soluble tablets (2) (P=0.041). In both centres dexamethasone was associated with less side effects. Vomiting (1 vs 0 patients), nausea (7 vs 3) and abdominal pain (10 vs 8) occurred more with dexamethasone Sodium Phosphate solution than dexamethasone elixir. Conclusions: Dexamethasone Sodium Phosphate solution was the most palatable preparation. Prednisolone base tablets were rated least palatable and were least well tolerated. Palatability scores improved with each dose taken.

  • TOLERABILITY OF Prednisolone AND DEXAMETHASONE IN CHILDREN IN SAUDI ARABIA
    Archives of disease in childhood, 2016
    Co-Authors: Fahad Aljebab, Mofadhi Alanazi, Imti Choonara, Sharon Conroy
    Abstract:

    Background 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. Methods Prospective observational and interview study. The palatability of the oral corticosteroids was evaluated by asking children and their parent9s 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. Results 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. Conclusions 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.

  • LONG-COURSE ORAL CORTICOSTEROID TOXICITY IN CHILDREN.
    Archives of disease in childhood, 2016
    Co-Authors: Fahad Aljebab, Imti Choonara, Sharon Conroy
    Abstract:

    Background Multiple studies have evaluated and reported adverse drug reactions (ADRs) of corticosteroids. Short course oral corticosteroids are commonly used in children in the management of conditions such as asthma exacerbations. This systematic review aimed to identify the most common and serious ADRs associated with short courses of oral corticosteroids and to determine their relative risk levels in children. Methods A literature search of several databases; Embase, Medline, International Pharmaceutical Abstracts, CINAHL, the Cochrane Library and PubMed was performed to identify all studies where corticosteroids had been administered to paediatric patients ranging from 28 days to 18 years of age for up to and including 14 days of treatment. Each database was searched from their earliest dates to December 2013. All types of studies that provided clear information on adverse events were included with no language restrictions. Quality assessments were performed on all studies by two independent reviewers. Results Thirty eight studies met the inclusion criteria. These studies represented 3202 children and contained reports of 847 adverse events. The three most frequent ADRs were vomiting, increased blood pressure and behavioural changes. The incidence rates of these three ADRs were 6.3%, 8.5% and 4.8%, of patients respectively. The risk of vomiting was greater with oral Prednisolone than oral dexamethasone with a relative risk of 3.62 (95% CI 1.89, 6.95; P=0.0001, I 2 =30%). Prednisolone Sodium Phosphate was reported to cause vomiting less frequently than other Prednisolone dosage forms (P=0.047). HPA axis suppression was detected in 43 of 53 patients who were tested. The relative risk of oral Prednisolone to cause HPA axis suppression compared with inhaled steroids was 9.95 (95% CI 1.73, 53.03; P=0.010, I 2 =54%). Increased susceptibility to infection was one of the most serious ADRs, one child died after contracting a varicella zoster infection. Conclusions Vomiting, increased blood pressure and behavioural changes were the most frequent ADRs seen when short-course oral corticosteroids were given to children. In addition, increased susceptibility to infection was the most serious ADR. The majority of children who received short course oral corticosteroids will experience HPA axis suppression.

  • SHORT-COURSE ORAL CORTICOSTEROID TOXICITY IN CHILDREN
    Archives of Disease in Childhood, 2015
    Co-Authors: Fahad Ajebab, Imti Choonara, Sharon Conroy
    Abstract:

    BackgroundMultiple studies have evaluated and reported adverse drug reactions (ADRs) of corticosteroids. Short course oral corticosteroids are commonly used in children in the management of conditions such as asthma exacerbations. This systematic review aimed to identify the most common and serious ADRs associated with short courses of oral corticosteroids and to determine their relative risk levels in children.MethodsA literature search of the databases: Embase, Medline, International Pharmaceutical Abstracts, CINAHL, the Cochrane Library and PubMed was performed to identify all studies where corticosteroids had been administered to paediatric patients ranging from 28 days to 18 years of age for up to and including 14 days of treatment. Each database was searched from their earliest dates to December 2013. All types of studies that provided clear information on adverse events were included with no language restrictions. Quality assessments were performed on all studies by two independent reviewers.ResultsThirty eight studies met the inclusion criteria. These studies represented 3202 children and contained reports of 847 adverse events. The three most frequent ADRs were vomiting, increased blood pressure and behavioural changes. The incidence rates of these three ADRs were 6.3%, 8.5% and 4.8% of patients respectively. The risk of vomiting was greater with oral Prednisolone than oral dexamethasone with a relative risk of 3.62 (95% CI 1.89, 6.95; P=0.0001). Prednisolone Sodium Phosphate was reported to cause vomiting less frequently than other Prednisolone dosage forms (P=0.047). HPA axis suppression was detected in 43 of 53 patients who were tested. The relative risk of oral Prednisolone to cause HPA axis suppression compared with inhaled steroids was 9.95 (95% CI 1.73, 53.03; P=0.010). Infection was one of the most serious ADRs, one child died after contracting a varicella zoster infection.ConclusionsVomiting, increased blood pressure and behavioural changes were the most frequent ADRs seen when short-course oral corticosteroids were given to children. In addition, infection was the most serious ADR. The majority of children who receive short course oral corticosteroids will experience HPA axis suppression.

Muthiah Srinivasan - One of the best experts on this subject based on the ideXlab platform.

  • The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial.
    American journal of ophthalmology, 2013
    Co-Authors: Muthiah Srinivasan, Jeena Mascarenhas, Revathi Rajaraman, Meenakshi Ravindran, Prajna Lalitha, Kieran S. O’brien, David V Glidden, Kathryn J Ray, Catherine E Oldenburg, Michael E. Zegans
    Abstract:

    Purpose To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. Design Randomized, placebo-controlled, double-masked clinical trial. Methods This multicenter trial compared 1.0% Prednisolone Sodium Phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. Results No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: −0.04 logMAR, 95% CI, −0.12 to 0.05, P  = .39; scar size: 0.03 mm, 95% CI, −0.12 to 0.18, P  = .69). A regression model including a Nocardia -treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non- Nocardia ulcers (−0.10 logMAR, 95% CI, −0.19 to −0.02, P  = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, −0.04 to 0.41, P  = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P  = .02) and no significant difference was identified by treatment for scar size for non- Nocardia ulcers (−0.06 mm, 95% CI, −0.21 to 0.10, P  = .46). Conclusions Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species.

  • corticosteroids for bacterial keratitis the steroids for corneal ulcers trial scut
    Archives of Ophthalmology, 2012
    Co-Authors: Muthiah Srinivasan, Jeena Mascarenhas, Revathi Rajaraman, Meenakshi Ravindran, Prajna Lalitha, David V Glidden, Kathryn J Ray, Catherine E Oldenburg, Kevin C Hong, Salena M Lee
    Abstract:

    Objective To determine whether there is a benefit in clinical outcomes with the use of topical corticosteroids as adjunctive therapy in the treatment of bacterial corneal ulcers. Methods Randomized, placebo-controlled, double-masked, multicenter clinical trial comparing Prednisolone Sodium Phosphate, 1.0%, to placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and received topical moxifloxacin for at least 48 hours before randomization. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months from enrollment. Secondary outcomes included infiltrate/scar size, reepithelialization, and corneal perforation. Results Between September 1, 2006, and February 22, 2010, 1769 patients were screened for the trial and 500 patients were enrolled. No significant difference was observed in the 3-month BSCVA (−0.009 logarithm of the minimum angle of resolution [logMAR]; 95% CI, −0.085 to 0.068; P = .82), infiltrate/scar size (P = .40), time to reepithelialization (P = .44), or corneal perforation (P >> .99). A significant effect of corticosteroids was observed in subgroups of baseline BSCVA (P = .03) and ulcer location (P = .04). At 3 months, patients with vision of counting fingers or worse at baseline had 0.17 logMAR better visual acuity with corticosteroids (95% CI, −0.31 to −0.02; P = .03) compared with placebo, and patients with ulcers that were completely central at baseline had 0.20 logMAR better visual acuity with corticosteroids (−0.37 to −0.04; P = .02). Conclusions We found no overall difference in 3-month BSCVA and no safety concerns with adjunctive corticosteroid therapy for bacterial corneal ulcers. Application to Clinical Practice Adjunctive topical corticosteroid use does not improve 3-month vision in patients with bacterial corneal ulcers. Trial Registration clinicaltrials.gov Identifier: NCT00324168

Jörg Kreuter - One of the best experts on this subject based on the ideXlab platform.

  • Influence of chitosan microspheres on the transport of Prednisolone Sodium Phosphate across HT-29 cell monolayers.
    Pharmaceutical research, 1998
    Co-Authors: Frank Ch. Mooren, A Berthold, Wolfram Domschke, Jörg Kreuter
    Abstract:

    Purpose. The present study was performed to investigate the influence of chitosan microspheres on transport of the hydrophilic, antiinflammatory drug Prednisolone Sodium Phosphate (PSP) across the epithelial barrier.

  • Influence of Chitosan Microspheres on the Transport of Prednisolone Sodium Phosphate Across HT-29 Cell Monolayers
    Pharmaceutical Research, 1998
    Co-Authors: Frank Ch. Mooren, A Berthold, Wolfram Domschke, Jörg Kreuter
    Abstract:

    Purpose . The present study was performed to investigate the influence of chitosan microspheres on transport of the hydrophilic, antiinflammatory drug Prednisolone Sodium Phosphate (PSP) across the epithelial barrier. Methods . Microspheres were prepared using a precipitation method and loaded with PSP. Transport studies were performed in a diffusion cell chamber using the polarized human cell line HT-29_B6. Porcine small intestine and fluorescence-labeled microspheres were used to investigate penetration ability of microspheres. Results . It was shown that transport of PSP drug solution was not saturable across the cell monolayers (P = 8.68 ± 8.24 × 10^−6 cm sec^−1) and no Sodium dependency could be established. EGTA treatment resulted in an increased permeability (P = 18.69 ± 1.09 × 10^−6 cm sec^−1). After binding of Prednisolone to chitosan microspheres its permeability was enhanced drastically compared with the drug solution (P = 35.37 ± 3.21 ×10^−6 cm sec^−1). This effect was prevented by EGTA treatment (P = 15.11 ± 2.57 × 10^−6 cm sec^−1). Furthermore the supporting effect of chitosan microspheres was impaired by pH and ion composition of the medium, whereas the effect remained unchanged in cells treated with bacterial lipopolysaccharides. In vitro incubation of fluorescence-labeled microspheres in the lumen of freshly excised intestine revealed a significant amount of the spheres in the submucosa. Conclusions . Chitosan microspheres are a useful tool to improve the uptake of hydrophilic substances like PSP across epithelial layers. The effect is dependent on the integrity of the intercellular cell contact zones and the microparticles are able to pass the epithelial layer. Their potential benefit under inflammatory conditions like in inflammatory bowel disease, in order to establish high drug doses at the region of interest, remains to be shown.

  • Collagen microparticles: carriers for glucocorticosteroids
    European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 1998
    Co-Authors: A. Berthold, Karsten Cremer, Jörg Kreuter
    Abstract:

    Collagen microparticles were evaluated as a carrier system for glucocorticoids, and their physicochemical characteristics were determined. The particles were prepared by emulsifying and cross-linking native collagen. Particles in a size range of about 10 μm were obtained. The particle charge was dependent on the pH. A positive charge resulted when the surrounding medium had a pH below 4.5 and a negative charge with a pH above 4.5. This charge determined the magnitude of the interaction with dissolved charged drugs. The positively charged drug, prednylidene diethylaminoacetate, bound significantly to the particles above pH 4.5, whereas the negatively charged Prednisolone Sodium Phosphate was bound below this pH. Adsorption of uncharged lipophilic drugs such as hydrocortisone was largely independent of the pH. The adsorption isotherm for this drug was determined and found to follow a Langmuir adsorption isotherm. The release and stability of the microparticle system was tested with hydrocortisone only, because of its pH-independent binding properties to the particles. The liberation of this drug was not influenced by the pH of the release medium. Binding to the particles did not effect the stability of hydrocortisone. The results of this study demonstrate that collagen microparticles can be successfully used as a carrier system for lipophilic steroids.