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The Pediatric Forum |

Can the Efficacy of Hypertonic Saline in Bronchiolitis Truly Be Assessed With a Short-term Primary Outcome?

Daniel Horner, MBBS, BSc, MRCP, MCEM; Thomas Bartram, MBChB, MRCS, MCEM; Rachel Jenner, MBChB, FRCSEd, FCEM; Rosemary Morton, MBChB, FRCS, FRCP,  FFAEM, FRCPCH
[+] Author Affiliations

Author Affiliations: Emergency Department, Manchester Royal Infirmary, Manchester, England (Dr Horner); Blackpool Fylde and Wyre National Health Service Foundation Trust, Blackpool, England (Dr Bartram); and Royal Manchester Childrens Hospital, Manchester (Drs Jenner and Morton).


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Arch Pediatr Adolesc Med. 2010;164(4):395-395. doi:10.1001/archpediatrics.2010.36
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Grewal et al1 should be congratulated for their recent study concerning the use of 3% hypertonic saline in the treatment of bronchiolitis. It is refreshing to see such a well-conducted pediatric trial based in the emergency department (ED). We would, however, make several points regarding the methodology of the study and raise concerns about the ultimate message. We believe that the efficacy of the treatment must be looked at in the wider context of the patient journey.

Although the trial was adequately powered to detect what was thought to be a clinically significant decrease in the Respiratory Assessment Change Score (RACS) during 120 minutes, we take issue with this as the primary outcome for 2 reasons. First, much of the data used in the Cochrane review2 was based on assessment of severity scores at more delayed intervals, such as 24 and 48 hours posttreatment. In the pooled data at these stages, a statistically significant decrease in severity score was seen in the hypertonic saline group. We suggest that in many patients, 120 minutes is too short to see meaningful improvement in a mild to moderate case of bronchiolitis. Therefore the results from Grewal et al may be misleadingly pessimistic. Second, we believe that the RACS is an overcomplicated tool to assess treatment benefit, based on its multiple variables, subjective criteria, and lack of nonrespiratory data. We find both the Kristjansson3 and Wang4 clinical respiratory scores easier to use and more comprehensive assessments of morbidity.

The authors go on to discuss the secondary outcomes: number of admissions and returns to the ED. Although the results unfortunately did not reach statistical significance, they demonstrate a clear trend toward a reduction in admissions with the use of hypertonic saline. The authors go on to mention in their discussion that the lack of significance is likely due to the small number of trial patients. Had they powered for this as the primary outcome, though the results would have taken longer to attain, they may have borne more fruit.

In our opinion, the available data suggest that hypertonic saline, when given early and regularly in mild to moderate bronchiolitis, results in decreased severity of symptoms and can reduce total hospital stay. Just because we do not see the direct results of initiating a treatment in the ED does not mean it is of no use. It is imperative to remember that the patient journey often extends well beyond the ED and if safe therapy that may be beneficial along this course exists, then we can and should implement it.

AUTHOR INFORMATION

Correspondence: Dr Horner, Emergency Department, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, England (danhorner@doctors.net.uk).

Author Contributions:Study concept and design: Horner, Bartram, and Jenner. Analysis and interpretation of data: Morton. Drafting of the manuscript: Horner, Bartram, and Jenner. Critical revision of the manuscript for important intellectual content: Morton. Administrative, technical, and material support: Bartram. Study supervision: Jenner.

Financial Disclosure: None reported.

Grewal  S, Ali  S, McConnell  DW, Vandermeer  B, Klassen  TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med 2009;163 (11) 1007- 1012
PubMed
Zhang  L, Mendoza-Sassi  RA, Wainwright  C, Klassen  TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev 2008; (4) CD006458
PubMed
Chin  HJ, Seng  QB. Reliability and validity of the respiratory score in the assessment of acute bronchiolitis. Malaysian J Med Sci 2004;11 (2) 34- 40
Wang  EEL, Milner  RA, Navas  L, Maj  H. Observer agreement for respiratory signs and oximetry in infants hospitalised with lower respiratory infections. Am Rev Respir Dis 1992;145 (1) 106- 109
PubMed

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Grewal  S, Ali  S, McConnell  DW, Vandermeer  B, Klassen  TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med 2009;163 (11) 1007- 1012
PubMed
Zhang  L, Mendoza-Sassi  RA, Wainwright  C, Klassen  TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev 2008; (4) CD006458
PubMed
Chin  HJ, Seng  QB. Reliability and validity of the respiratory score in the assessment of acute bronchiolitis. Malaysian J Med Sci 2004;11 (2) 34- 40
Wang  EEL, Milner  RA, Navas  L, Maj  H. Observer agreement for respiratory signs and oximetry in infants hospitalised with lower respiratory infections. Am Rev Respir Dis 1992;145 (1) 106- 109
PubMed

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