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Two RCTs of hypertonic saline in kids with bronchiolitis: 2 different conclusions

Clinical Question:
Is hypertonic saline effective in decreasing hospitalizations and the severity of symptoms in children with acute bronchiolitis?

Bottom Line:
These 2 high-quality studies reach divergent conclusions. Wu and colleagues found that children with acute bronchiolitis treated with hypertonic saline have fewer hospitalizations than children treated with normal saline, but the symptom improvement is comparable. Florin and colleagues found that children treated with hypertonic saline didn't do as well as children treated with normal saline (they don’t report hospitalizations). What accounts for the divergence? Most likely it is the very small sample size of the Florin study. Small studies tend to demonstrate more "noise" than larger studies. This is supported by a 2013 Cochrane review that reported that hypertonic saline is effective. (LOE = 1b)

Wu S, Baker C, Lang ME, et al. Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial. JAMA Pediatr 2014;168(7):657-663. Florin TA, Shaw KN, Kittick M, Yakscoe S, Zorc JJ. Nebulized hypertonic saline for bronchiolitis in the emergency department: a randomized clinical trial. JAMA Pediatr 2014;168(7):664-670. department: a randomized clinical trial. JAMA Pediatr 2014;168(7):664-70.  [PMID:24862623]

Study Design:
Randomized controlled trial (double-blinded)



Emergency department

Here we have 2 different, well-conducted studies. Each study recruited similar patients (children presenting to an emergency department with acute bronchiolitis) and compared 4 mL hypertonic saline (3%) with 4 mL normal saline (0.9%) delivered via nebulizer. Each used the Respiratory Distress Assessment Instrument (RDAI) to assess the children's response to treatment. Each used good methods to decrease bias (concealed allocation, masking, and so forth). Wu and colleagues enrolled more than 400 children who were recruited during 3 different bronchiolitis seasons. Only 2 children in each group weren't included in the final analysis. Although only 29% of children treated with hypertonic saline were admitted compared with 43% treated with normal saline (number needed to treat = 8; 95% CI, 5 - 23), the authors found no difference in the duration of the hospitalizations. Each group had improvements in the RDAI score, but the improvements weren't significantly different. On the other hand, Florin and colleagues recruited 62 children and found that the children treated with hypertonic saline had significantly less improvement in their RDAI scores than the children treated with normal saline. They didn't report on hospitalization rates.


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