A Randomized Trial of Nebulized 3% Hypertonic
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Transcript A Randomized Trial of Nebulized 3% Hypertonic
A Randomized Trial of Nebulized 3%
Hypertonic Saline With Epinephrine in the
Treatment of Acute Bronchiolitis in the
Emergency Department
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.
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Introduction
• Bronchiolitis in infants creates great burden of disease
• Four trials have investigated use of nebulized 3%
hypertonic saline for bronchiolitis
– Two showed improvement in clinical severity scores
– Two showed reduction in length of hospital stay
• No studies had been done in the emergency department
(ED), which is often the entry point for medical care
• Objective: To determine whether nebulized 3%
hypertonic saline with epinephrine is more effective than
nebulized 0.9% saline with epinephrine in the treatment
of bronchiolitis in the ED
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Methods
• Randomized, double-blind, controlled trial
• N = 46 infants (aged <1 year) with mild to moderate
bronchiolitis
• Randomized to receive nebulized racemic epinephrine in
either hypertonic or normal saline
• Primary outcome was change in respiratory distress, as
measured by the Respiratory Assessment Change Score
(RACS) from baseline to 120 minutes
• Secondary outcomes: change in oxygen saturation, rate of
hospital admission, and rate of return to the ED
• Study was supported by the Department of Pediatrics,
University of Alberta, and the Alberta Research Centre for
Child Health Evidence
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Methods
• Intention-to-treat principle was used in all analyses
• Linear multivariable regression analysis was performed
to determine whether RACS was influenced by type of
solution, second dose of the study drug, family history of
asthma, sex, smoke exposure, age in days, and how
well the infant fed
• Limitations: No 24/7 coverage during study period; no
placebo group; maximum of only 2 doses of the study
drug were given; study period was only 120 minutes
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Results
• Forty-six patients enrolled and evaluated
• No improvement in respiratory distress (RACS) from
baseline to 120 minutes in the hypertonic saline group
compared with the normal saline control group
• Change in oxygen saturation in the hypertonic saline
group was not significantly different from that in the
control group
• Rates of admission and return to the ED were not
significantly different between the 2 groups
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Results
Clinical Outcomes of the 2 Groups
Mean (95% CI)
Variable
Hypertonic Saline
Normal Saline
Difference
Change in RACS
4.39 (2.64 to 6.13)
5.13 (3.71 to 6.55)
0.74 (−1.45 to 2.93)
Change in O2 saturation
−0.44 (−2.11 to 1.23)
1.34 (−0.29 to 2.99)
1.78 (−0.50 to 4.06)
Abbreviations: CI, confidence interval; RACS, Respiratory Assessment Change Score.
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Results
Secondary Outcomes
No./Total
Variable
RR (95% CI)
Hypertonic Saline
Normal Saline
Admissions to hospital
8/23
13/23
0.61 (0.22-1.19)
Returns to ED
3/23
4/23
0.74 (0.11-2.91)
Abbreviations: CI, confidence interval; ED, emergency department; RR, risk ratio.
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Discussion
• Although not statistically significant, there was a trend
toward a decreased rate of hospitalization in the
hypertonic saline group
• While hypertonic saline may not show immediate ED
benefits, there is a suggestion that perhaps it should be
initiated in the ED for later (inpatient) benefit
• This is the first study of hypertonic saline for bronchiolitis
in the ED
• This is the first negative study of epinephrine and
hypertonic saline in bronchiolitis
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Discussion
• Need for further research to determine whether
hypertonic saline does have a role in the treatment of
bronchiolitis in the ED and in subsequent hospitalization
• Future studies should extend the period of time in which
treated patients are observed, as the effects of
hypertonic saline may be seen outside the immediate
treatment time (ie, 120 minutes)
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Contact Information
• If you have questions, you may contact the
corresponding author, Simran Grewal, MD:
– Email: [email protected]
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