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Positive expiratory pressure for the treatment of acute asthma exacerbations: a randomized controlled trial |
Navanandan N, Federico M, Mistry RD |
The Journal of Pediatrics 2017 Jun;185:149-154 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVES: To evaluate the efficacy of brief, single administration of positive expiratory pressure (PEP) therapy in reducing clinical severity and need for additional second-line therapies and hospitalization in children presenting to the emergency department (ED) with acute asthma. STUDY DESIGN: This was a prospective randomized controlled trial of children 2 to 18 years of age presenting to a tertiary-care academic pediatric ED with moderate-to-severe asthma exacerbations from December 2014 to June 2016. Children who continued to have moderate asthma severity after completion of initial therapies (albuterol/ipratropium bromide and corticosteroids) were randomized to receive PEP therapy or standard of care. The primary outcome was change in pulmonary asthma score before and after intervention, as assessed by a blinded physician. Secondary outcomes included need for additional therapies, ED length of stay, and disposition. RESULTS: A total of 52 patients were randomized to receive either PEP (n = 26) or standard therapy (n = 26). Study groups were similar in demographics and baseline characteristics. There was no significant difference in primary outcome between groups with a mean change in Pulmonary Asthma Score of 0.92 (+/- 1.2) in the PEP group and 0.40 (+/- 1.2) in the standard group (p = 0.12). There also was no significant difference in need for additional therapies, ED length of stay, and disposition. Mild, self-resolving side effects were observed in 3 subjects receiving PEP therapy. CONCLUSION: Single, brief, administration of PEP therapy after completion of first-line therapies does not improve clinical severity in children presenting to the ED with acute asthma. TRIAL REGISTRATION: ClinicalTrials.gov NCT02494076.
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