John J Cronin1, Siobhan McCoy1, Una Kennedy2, Sinéad Nic An Fhailí3, Abel Wakai4, John Hayden3, Gloria Crispino5, Michael J Barrett6, Sean Walsh1, Ronan O'Sullivan7. 1. Paediatric Emergency Research Unit, National Children's Research Centre, Dublin 12, Ireland; Department of Emergency Medicine, Our Lady's Children's Hospital, Crumlin, Dublin 12, Ireland. 2. Department of Emergency Medicine, St James's Hospital, Dublin 8, Ireland. 3. Paediatric Emergency Research Unit, National Children's Research Centre, Dublin 12, Ireland. 4. Emergency Care Research Unit, Division of Population Health Sciences, Royal College of Surgeons, Dublin 2, Ireland. 5. StatisticaMedica Ltd., Dublin 18, Ireland. 6. Paediatric Emergency Research Unit, National Children's Research Centre, Dublin 12, Ireland; Department of Emergency Medicine, Our Lady's Children's Hospital, Crumlin, Dublin 12, Ireland; Department of Paediatrics, University College Dublin, Belfield, Dublin 4, Ireland. 7. Paediatric Emergency Research Unit, National Children's Research Centre, Dublin 12, Ireland; Department of Emergency Medicine, Our Lady's Children's Hospital, Crumlin, Dublin 12, Ireland; Department of Paediatrics, University College Dublin, Belfield, Dublin 4, Ireland; School of Medicine, University College Cork, Cork, Ireland. Electronic address: ronanosullivan@ucc.ie.
Abstract
STUDY OBJECTIVE: In acute exacerbations of asthma in children, corticosteroids reduce relapses, subsequent hospital admission, and the need for ß2-agonist bronchodilators. Prednisolone is the most commonly used corticosteroid, but prolonged treatment course, vomiting, and a bitter taste may reduce patient compliance. Dexamethasone has a longer half-life and has been used safely in other acute pediatric conditions. We examine whether a single dose of oral dexamethasone is noninferior to prednisolone in the emergency department (ED) treatment of asthma exacerbations in children, as measured by the Pediatric Respiratory Assessment Measure (PRAM) at day 4. METHODS: We conducted a randomized, open-label, noninferiority trial comparing oral dexamethasone (single dose of 0.3 mg/kg) with prednisolone (1 mg/kg per day for 3 days) in patients aged 2 to 16 years and with a known diagnosis of asthma or at least 1 previous episode of ß2-agonist-responsive wheeze who presented to a tertiary pediatric ED. The primary outcome measure was the mean PRAM score (range of 0 to 12 points) performed on day 4. Secondary outcome measures included requirement for further steroids, vomiting of study medication, hospital admission, and unscheduled return visits to a health care practitioner within 14 days. RESULTS: There were 245 enrollments involving 226 patients. There was no difference in mean PRAM scores at day 4 between the dexamethasone and prednisolone groups (0.91 versus 0.91; absolute difference 0.005; 95% CI -0.35 to 0.34). Fourteen patients vomited at least 1 dose of prednisolone compared with no patients in the dexamethasone group. Sixteen children (13.1%) in the dexamethasone group received further systemic steroids within 14 days after trial enrollment compared with 5 (4.2%) in the prednisolone group (absolute difference 8.9%; 95% CI 1.9% to 16.0%). There was no significant difference between the groups in hospital admission rates or the number of unscheduled return visits to a health care practitioner. CONCLUSION: In children with acute exacerbations of asthma, a single dose of oral dexamethasone (0.3 mg/kg) is noninferior to a 3-day course of oral prednisolone (1 mg/kg per day) as measured by the mean PRAM score on day 4.
RCT Entities:
STUDY OBJECTIVE: In acute exacerbations of asthma in children, corticosteroids reduce relapses, subsequent hospital admission, and the need for ß2-agonist bronchodilators. Prednisolone is the most commonly used corticosteroid, but prolonged treatment course, vomiting, and a bitter taste may reduce patient compliance. Dexamethasone has a longer half-life and has been used safely in other acute pediatric conditions. We examine whether a single dose of oral dexamethasone is noninferior to prednisolone in the emergency department (ED) treatment of asthma exacerbations in children, as measured by the Pediatric Respiratory Assessment Measure (PRAM) at day 4. METHODS: We conducted a randomized, open-label, noninferiority trial comparing oral dexamethasone (single dose of 0.3 mg/kg) with prednisolone (1 mg/kg per day for 3 days) in patients aged 2 to 16 years and with a known diagnosis of asthma or at least 1 previous episode of ß2-agonist-responsive wheeze who presented to a tertiary pediatric ED. The primary outcome measure was the mean PRAM score (range of 0 to 12 points) performed on day 4. Secondary outcome measures included requirement for further steroids, vomiting of study medication, hospital admission, and unscheduled return visits to a health care practitioner within 14 days. RESULTS: There were 245 enrollments involving 226 patients. There was no difference in mean PRAM scores at day 4 between the dexamethasone and prednisolone groups (0.91 versus 0.91; absolute difference 0.005; 95% CI -0.35 to 0.34). Fourteen patients vomited at least 1 dose of prednisolone compared with no patients in the dexamethasone group. Sixteen children (13.1%) in the dexamethasone group received further systemic steroids within 14 days after trial enrollment compared with 5 (4.2%) in the prednisolone group (absolute difference 8.9%; 95% CI 1.9% to 16.0%). There was no significant difference between the groups in hospital admission rates or the number of unscheduled return visits to a health care practitioner. CONCLUSION: In children with acute exacerbations of asthma, a single dose of oral dexamethasone (0.3 mg/kg) is noninferior to a 3-day course of oral prednisolone (1 mg/kg per day) as measured by the mean PRAM score on day 4.
Authors: Jillian M Cotter; Amy Tyler; Jennifer Reese; Sonja Ziniel; Monica J Federico; William C Anderson Iii; Oren Kupfer; Stanley J Szefler; Gwendolyn Kerby; Heather E Hoch Journal: J Asthma Date: 2019-06-12 Impact factor: 2.515
Authors: Bhupendrasinh F Chauhan; Maya M Jeyaraman; Amrinder Singh Mann; Justin Lys; Ahmed M Abou-Setta; Ryan Zarychanski; Francine M Ducharme Journal: Cochrane Database Syst Rev Date: 2017-03-16
Authors: Catherine M Pound; Jaime McDonald; Ken Tang; Gillian Seidman; Radha Jetty; Sarah Zaidi; Amy C Plint Journal: BMJ Open Date: 2018-12-14 Impact factor: 2.692