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Original Investigation | Journal Club

Nebulized Hypertonic Saline for Bronchiolitis in the Emergency Department:  A Randomized Clinical Trial

Todd A. Florin, MD, MSCE1,2; Kathy N. Shaw, MD, MSCE3,4; Marlena Kittick, MPH3; Stephen Yakscoe, BA3; Joseph J. Zorc, MD, MSCE3,4
[+] Author Affiliations
1Division of Pediatric Emergency Medicine, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio
2Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, Ohio
3Division of Pediatric Emergency Medicine, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
4Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia
JAMA Pediatr. 2014;168(7):664-670. doi:10.1001/jamapediatrics.2013.5306.
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Importance  Acute bronchiolitis is the most frequent lower respiratory tract infection in infants, yet there are no effective therapies available. Current evidence is unclear about the role of hypertonic saline (HS) for the acute treatment of bronchiolitis.

Objective  To determine whether nebulized 3% HS compared with normal saline (NS) improves respiratory distress in infants with bronchiolitis not responding to standard treatments in the emergency department.

Design, Setting, and Participants  A randomized clinical trial with blinding of investigators, health care providers, and parents was conducted at a single urban pediatric ED. The participants included children aged 2 to less than 24 months with their first episode of bronchiolitis and a Respiratory Distress Assessment Instrument score of 4 to 15 after nasal suctioning and a trial of nebulized albuterol.

Interventions  Patients were randomized to receive either nebulized 3% HS (HS group) or NS (NS group).

Main Outcomes and Measures  The primary outcome was change in respiratory distress at 1 hour after the intervention, as measured by the Respiratory Assessment Change Score (a decrease indicates improvement). Secondary outcomes included vital signs, oxygen saturation, hospitalization, physician clinical impression, parental assessment, and adverse events.

Results  The 31 patients enrolled in each treatment arm had similar baseline demographic and clinical characteristics. At 1 hour after the intervention, the HS group demonstrated significantly less improvement in the median Respiratory Assessment Change Score compared with the NS group (HS, −1 [interquartile range, −5 to 1] vs NS, −5 [interquartile range, −6 to −2]; P = .01). There were no significant differences in heart rate, oxygen saturation, hospitalization rate, or other outcomes. There were no adverse events.

Conclusions and Relevance  Infants with bronchiolitis and persistent respiratory distress after standard treatment in the emergency department had less improvement after receiving 3% HS compared with those who received NS. Based on these results and the existing evidence, administration of a single dose of 3% HS does not appear to be indicated to treat bronchiolitis in the acute care setting.

Trial Registration  clinicaltrials.gov Identifier: NCT01247064

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Figure 1.
Consolidated Standards for Reporting of Trials Study Flow Diagram

HS indicates hypertonic saline; NS, normal saline; and RDAI, Respiratory Distress Assessment Instrument.

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Figure 2.
Respiratory Assessment Change Score (RACS) Values 1 Hour After HS and NS Administration

Each bar represents an infant’s RACS 1 hour after administration of study medication. Lower numbers indicate improvement in respiratory symptoms. The dashed line represents a clinically significant improvement. HS indicates hypertonic saline; NS, normal saline.

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