A Randomized Trial of Single-Dose Oral Dexamethasone Versus Multidose Prednisolone for Acute Exacerbations of Asthma in Children Who Attend the Emergency Department

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 p...

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Veröffentlicht in:Annals of emergency medicine 2016-05, Vol.67 (5), p.593-601.e3
Hauptverfasser: Cronin, John J., MB, AFRCSI, McCoy, Siobhan, RGN, RCN, Kennedy, Una, FRCEM, an Fhailí, Sinéad Nic, PhD, MICR, Wakai, Abel, MD, FRCEM, Hayden, John, BPharm, Crispino, Gloria, PhD, CStat, Barrett, Michael J., MB, MRCPI, Walsh, Sean, FRCEM, O’Sullivan, Ronan, FPAEDS, MBA
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container_end_page 601.e3
container_issue 5
container_start_page 593
container_title Annals of emergency medicine
container_volume 67
creator Cronin, John J., MB, AFRCSI
McCoy, Siobhan, RGN, RCN
Kennedy, Una, FRCEM
an Fhailí, Sinéad Nic, PhD, MICR
Wakai, Abel, MD, FRCEM
Hayden, John, BPharm
Crispino, Gloria, PhD, CStat
Barrett, Michael J., MB, MRCPI
Walsh, Sean, FRCEM
O’Sullivan, Ronan, FPAEDS, MBA
description 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.
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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.</description><identifier>ISSN: 0196-0644</identifier><identifier>EISSN: 1097-6760</identifier><identifier>DOI: 10.1016/j.annemergmed.2015.08.001</identifier><identifier>PMID: 26460983</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acute Disease ; Administration, Oral ; Adolescent ; Anti-Asthmatic Agents - administration &amp; dosage ; Anti-Inflammatory Agents - administration &amp; dosage ; Asthma - drug therapy ; Asthma - physiopathology ; Child ; Child, Hospitalized ; Child, Preschool ; Critical Pathways ; Dexamethasone - administration &amp; dosage ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Emergency ; Emergency Medical Services ; Female ; Humans ; Male ; Prednisolone - administration &amp; dosage ; Severity of Illness Index ; Treatment Outcome</subject><ispartof>Annals of emergency medicine, 2016-05, Vol.67 (5), p.593-601.e3</ispartof><rights>American College of Emergency Physicians</rights><rights>2015 American College of Emergency Physicians</rights><rights>Copyright © 2015 American College of Emergency Physicians. 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All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c498t-5f78f73ebf33338ca2cb73fd86ef6d495d7396da8cfb2c4de2ced7175b7a0bd13</citedby><cites>FETCH-LOGICAL-c498t-5f78f73ebf33338ca2cb73fd86ef6d495d7396da8cfb2c4de2ced7175b7a0bd13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.annemergmed.2015.08.001$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26460983$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cronin, John J., MB, AFRCSI</creatorcontrib><creatorcontrib>McCoy, Siobhan, RGN, RCN</creatorcontrib><creatorcontrib>Kennedy, Una, FRCEM</creatorcontrib><creatorcontrib>an Fhailí, Sinéad Nic, PhD, MICR</creatorcontrib><creatorcontrib>Wakai, Abel, MD, FRCEM</creatorcontrib><creatorcontrib>Hayden, John, BPharm</creatorcontrib><creatorcontrib>Crispino, Gloria, PhD, CStat</creatorcontrib><creatorcontrib>Barrett, Michael J., MB, MRCPI</creatorcontrib><creatorcontrib>Walsh, Sean, FRCEM</creatorcontrib><creatorcontrib>O’Sullivan, Ronan, FPAEDS, MBA</creatorcontrib><title>A Randomized Trial of Single-Dose Oral Dexamethasone Versus Multidose Prednisolone for Acute Exacerbations of Asthma in Children Who Attend the Emergency Department</title><title>Annals of emergency medicine</title><addtitle>Ann Emerg Med</addtitle><description>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.</description><subject>Acute Disease</subject><subject>Administration, Oral</subject><subject>Adolescent</subject><subject>Anti-Asthmatic Agents - administration &amp; dosage</subject><subject>Anti-Inflammatory Agents - administration &amp; dosage</subject><subject>Asthma - drug therapy</subject><subject>Asthma - physiopathology</subject><subject>Child</subject><subject>Child, Hospitalized</subject><subject>Child, Preschool</subject><subject>Critical Pathways</subject><subject>Dexamethasone - administration &amp; dosage</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Emergency</subject><subject>Emergency Medical Services</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Prednisolone - administration &amp; 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McCoy, Siobhan, RGN, RCN ; Kennedy, Una, FRCEM ; an Fhailí, Sinéad Nic, PhD, MICR ; Wakai, Abel, MD, FRCEM ; Hayden, John, BPharm ; Crispino, Gloria, PhD, CStat ; Barrett, Michael J., MB, MRCPI ; Walsh, Sean, FRCEM ; O’Sullivan, Ronan, FPAEDS, MBA</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c498t-5f78f73ebf33338ca2cb73fd86ef6d495d7396da8cfb2c4de2ced7175b7a0bd13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Acute Disease</topic><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Anti-Asthmatic Agents - administration &amp; dosage</topic><topic>Anti-Inflammatory Agents - administration &amp; dosage</topic><topic>Asthma - drug therapy</topic><topic>Asthma - physiopathology</topic><topic>Child</topic><topic>Child, Hospitalized</topic><topic>Child, Preschool</topic><topic>Critical Pathways</topic><topic>Dexamethasone - administration &amp; dosage</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Emergency</topic><topic>Emergency Medical Services</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Prednisolone - administration &amp; dosage</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cronin, John J., MB, AFRCSI</creatorcontrib><creatorcontrib>McCoy, Siobhan, RGN, RCN</creatorcontrib><creatorcontrib>Kennedy, Una, FRCEM</creatorcontrib><creatorcontrib>an Fhailí, Sinéad Nic, PhD, MICR</creatorcontrib><creatorcontrib>Wakai, Abel, MD, FRCEM</creatorcontrib><creatorcontrib>Hayden, John, BPharm</creatorcontrib><creatorcontrib>Crispino, Gloria, PhD, CStat</creatorcontrib><creatorcontrib>Barrett, Michael J., MB, MRCPI</creatorcontrib><creatorcontrib>Walsh, Sean, FRCEM</creatorcontrib><creatorcontrib>O’Sullivan, Ronan, FPAEDS, MBA</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of emergency medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cronin, John J., MB, AFRCSI</au><au>McCoy, Siobhan, RGN, RCN</au><au>Kennedy, Una, FRCEM</au><au>an Fhailí, Sinéad Nic, PhD, MICR</au><au>Wakai, Abel, MD, FRCEM</au><au>Hayden, John, BPharm</au><au>Crispino, Gloria, PhD, CStat</au><au>Barrett, Michael J., MB, MRCPI</au><au>Walsh, Sean, FRCEM</au><au>O’Sullivan, Ronan, FPAEDS, MBA</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized Trial of Single-Dose Oral Dexamethasone Versus Multidose Prednisolone for Acute Exacerbations of Asthma in Children Who Attend the Emergency Department</atitle><jtitle>Annals of emergency medicine</jtitle><addtitle>Ann Emerg Med</addtitle><date>2016-05-01</date><risdate>2016</risdate><volume>67</volume><issue>5</issue><spage>593</spage><epage>601.e3</epage><pages>593-601.e3</pages><issn>0196-0644</issn><eissn>1097-6760</eissn><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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26460983</pmid><doi>10.1016/j.annemergmed.2015.08.001</doi></addata></record>
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subjects Acute Disease
Administration, Oral
Adolescent
Anti-Asthmatic Agents - administration & dosage
Anti-Inflammatory Agents - administration & dosage
Asthma - drug therapy
Asthma - physiopathology
Child
Child, Hospitalized
Child, Preschool
Critical Pathways
Dexamethasone - administration & dosage
Dose-Response Relationship, Drug
Drug Administration Schedule
Emergency
Emergency Medical Services
Female
Humans
Male
Prednisolone - administration & dosage
Severity of Illness Index
Treatment Outcome
title A Randomized Trial of Single-Dose Oral Dexamethasone Versus Multidose Prednisolone for Acute Exacerbations of Asthma in Children Who Attend the Emergency Department
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