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

被引:53
作者
Cronin, John J. [1 ,2 ]
McCoy, Siobhan [1 ,2 ]
Kennedy, Una [3 ]
Fhaili, Sinead Nic An [1 ]
Wakai, Abel [4 ]
Hayden, John [1 ]
Crispino, Gloria [5 ]
Barrett, Michael J. [1 ,2 ,6 ]
Walsh, Sean [1 ,2 ]
O'Sullivan, Ronan [1 ,2 ,6 ,7 ]
机构
[1] Natl Childrens Res Ctr, Paediat Emergency Res Unit, Dublin 12, Ireland
[2] Our Ladys Childrens Hosp, Dept Emergency Med, Dublin 12, Ireland
[3] St James Hosp, Dept Emergency Med, Dublin 8, Ireland
[4] Royal Coll Surgeons Ireland, Div Populat Hlth Sci, Emergency Care Res Unit, Dublin 2, Ireland
[5] StatisticaMedica Ltd, Dublin 18, Ireland
[6] Univ Coll Dublin, Dept Paediat, Dublin 4, Ireland
[7] Natl Univ Ireland Univ Coll Cork, Sch Med, Cork, Ireland
关键词
PEDIATRIC ASTHMA; INTRAMUSCULAR DEXAMETHASONE; MANAGEMENT; SEVERITY;
D O I
10.1016/j.annemergmed.2015.08.001
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
Study objective: In acute exacerbations of asthma in children, corticosteroids reduce relapses, subsequent hospital admission, and the need for beta(2)-agonist bronchodilators. Prednisolone is the most commonly used corticosteroid, but prolonged treatment course, vomiting, and a bitter take 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 82-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.
引用
收藏
页码:593 / 601
页数:9
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