Nebulized Hypertonic Saline Without Adjunctive Bronchodilators for Children

With Bronchiolitis
Shawn Ralston, Vanessa Hill and Marissa Martinez
Pediatrics 2010;126;e520; originally published online August 16, 2010;
DOI: 10.1542/peds.2009-3105

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/126/3/e520.full.html

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Nebulized Hypertonic Saline Without Adjunctive
Bronchodilators for Children With Bronchiolitis
WHAT’S KNOWN ON THIS SUBJECT: Multiple studies evaluated
nebulized hypertonic saline solution as a therapy for viral
bronchiolitis in young children. However, the available studies
AUTHORS: Shawn Ralston, MD,a,b Vanessa Hill, MD,a,b and
Marissa Martinez, MDb
aDepartment of Pediatrics, University of Texas Health Science

combined hypertonic saline solution with some form of Center at San Antonio, San Antonio, Texas; and bChristus Santa
Rosa Children’s Hospital, San Antonio, Texas
bronchodilator because of theoretical concerns that hypertonic
saline solution may cause bronchospasm. KEY WORDS
bronchiolitis, therapy, adverse effects, hypertonic saline
solution
WHAT THIS STUDY ADDS: This is the first study to investigate
systematically the risk of bronchospasm or other significant ABBREVIATION
CI—confidence interval
adverse effects with hypertonic saline solution administered
without bronchodilators for viral bronchiolitis. Dr Martinez’s current affiliation is QTC Medical Services, San
Antonio, TX.
www.pediatrics.org/cgi/doi/10.1542/peds.2009-3105
doi:10.1542/peds.2009-3105
Accepted for publication May 28, 2010
abstract Address correspondence to Shawn Ralston, MD, University of
Texas Health Science Center at San Antonio, Department of
OBJECTIVE: The goal was to determine an adverse event rate for neb- Pediatrics, 7703 Floyd Curl Dr, MSC 7829, San Antonio, TX 78229.
ulized hypertonic saline solution administered without adjunctive E-mail: ralstons@uthscsa.edu
bronchodilators for infants with bronchiolitis. PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
METHODS: This was a retrospective cohort study of the use of nebu- Copyright © 2010 by the American Academy of Pediatrics
lized 3% saline for children ⬍2 years of age who were hospitalized with FINANCIAL DISCLOSURE: The authors have indicated they have
the primary diagnosis of bronchiolitis at a single academic medical no financial relationships relevant to this article to disclose.
center. The medical records of study participants were analyzed for
the use of nebulized 3% saline solution and any documented adverse
events related to this therapy. Other clinical outcomes evaluated in-
cluded respiratory distress scores, timing of the use of bronchodila-
tors in relation to 3% saline solution, transfer to a higher level of care,
and readmission within 72 hours after discharge.
RESULTS: A total of 444 total doses of 3% saline solution were admin-
istered, with 377 doses (85%) being administered without adjunctive
bronchodilators. Four adverse events occurred with these 377 doses,
for a 1.0% adverse event rate (95% confidence interval: 0.3%–2.8%).
Adverse events were generally mild. One episode of bronchospasm
was documented, for a rate of 0.3% (95% confidence interval: ⬍0.01%–
1.6%).
CONCLUSIONS: The use of 3% saline solution without adjunctive bron-
chodilators for inpatients with bronchiolitis had a low rate of adverse
events in our center. Additional clinical trials of 3% saline solution in
bronchiolitis should evaluate its effectiveness in the absence of adjunc-
tive bronchodilators. Pediatrics 2010;126:e520–e525

e520 RALSTON et al
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Viral bronchiolitis is the most-common
reason for hospital admission for in-
fants, accounting for 20% of hospital-
izations at ⬍1 year of age.1 Meta-
analyses of data on the most-used
therapies, namely, nebulized albuterol
and epinephrine, failed to demon-
strate any effect on relevant clinical
outcomes, in comparison with place-
bo.2–5 Current clinical practice guide-
lines do not recommend the routine
use of any medication for bronchioli-
tis.6 Despite the evidence, use of inef-
fective therapies for bronchiolitis re-
mains high.7,8
Several studies reported on the use of
nebulized 3% saline solution for in-
fants with bronchiolitis, with the ma-
jority reporting substantial benefits of
therapy.9–12 Evidence suggests that hy-
pertonic saline solution favorably al-
ters mucociliary clearance in both nor-
mal and diseased lungs, in multiple
clinical settings.13–16 Because the
pathophysiologic characteristics of
bronchiolitis primarily involve airway
inflammation with increased mucus
production and mucus plugging, it is
logical to think that improved mucocili-
ary clearance would be beneficial in
bronchiolitis, although there is only in-
direct evidence that this is true.
The only significant adverse effect of
nebulized hypertonic saline solution is
the risk of bronchospasm. Use of neb-
ulized hypertonic saline solution is es-
tablished in the asthma literature as a
diagnostic test to distinguish individu-
als with asthma from those without
asthma.17 There is a fairly clear dose-
response relationship for hypertonic
saline solution and bronchospasm in
individuals with asthma.18 Typical con-
centrations used in studies of individ-
uals with asthma range from 4.5% to
7%, with widely varying volumes being
required to induce bronchospasm.19
Because the vast majority of patients
with bronchiolitis do not have asthma
and the pathophysiologic features of
PEDIATRICS Volume 126, Number 3, September 2010
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typical bronchiolitis do not involve
bronchial smooth muscle hyperre-
sponsiveness, concern regarding
bronchospasm resulting from the use
of 3% saline solution among patients
with bronchiolitis remains theoretical.
Most available studies on hypertonic
saline solution in bronchiolitis are
problematic because investigators co-
administered 3% saline solution with
bronchodilators, medications that are
known to be ineffective in the disease.
In only 1 study was any 3% saline solu-
tion administered without concomi-
tant bronchodilator treatment; al-
though only some of the patients in
that study received the medication
without bronchodilators, bronchos-
pasm was not a reported adverse ef-
fect.12 No evidence has established
that 3% saline solution induces bron-
chospasm in infants with bronchiolitis,
but its safety when used without ad-
junctive bronchodilators also has not
been established.
This study was undertaken because of
the emerging popularity of nebulized
3% saline solution in our center and
the variable use patterns noted. Our
primary goal was to gain more infor-
mation about the use of this new ther-
apy in our center, with a specific aim of
establishing a rate of adverse reac-
tions for 3% saline solution used with-
out adjunctive bronchodilators, to es-
tablish the safety of the intervention.
METHODS
Study Design
This was a retrospective cohort study
of infants hospitalized with bronchioli-
tis between December 15, 2008, and
March 15, 2009, at Christus Santa Rosa
Children’s Hospital. This study quali-
fied for exempt status from the Univer-
sity of Texas Health Science Center at
San Antonio institutional review board
and was approved by the Christus
Santa Rosa Children’s Hospital re-
search office.
ARTICLE
Study Setting
The Christus Santa Rosa Children’s
Hospital is an urban, nonprofit, chil-
dren’s hospital in San Antonio, Texas
(metropolitan area population of 2 mil-
lion), which serves a population cov-
ered primarily by public insurance
programs. Inpatient pediatric care is
provided by a group of academic pedi-
atric hospitalists employed by the Uni-
versity of Texas Health Science Center
at San Antonio, with ⬃15% of medical
service inpatients being cared for by
physicians in private practice. Yearly
admissions with the primary diagno-
sis of bronchiolitis in this institution
ranged between 350 –500 patients per
year over the past 5 years.
Inclusion Criteria
Inclusion criteria were age of ⬍2
years, primary diagnosis of acute vi-
ral bronchiolitis (International Clas-
sification of Diseases, Ninth Revision,
code 466.11 or 466.19), and hospital-
ization on 1 of the 2 medical service
floors at Christus Santa Rosa Chil-
dren’s Hospital. The time period was
chosen because of the availability of
an extensive database being main-
tained for an ongoing quality im-
provement project. The 2 medical
service floors were chosen for the
database because they hospitalized
the vast majority of patients with
bronchiolitis in the hospital, had a
fixed capacity from year to year, had
clear admission criteria (ie, no car-
diac monitoring), and had stable
nurse/patient ratios and therefore
would provide a stable denominator
with little variation in severity of dis-
ease for the quality improvement
project.
Exclusion Criteria
Exclusion criteria were the presence of
complicating underlying illnesses (bron-
chopulmonary dysplasia or chronic lung
disease, neuromuscular impairment,
e521
immunodeficiency, or congenital heart
disease).
Methods
Information was obtained through re-
view of an existing database docu-
menting all bronchiolitis hospitaliza-
tions on the regular medical service
floors. The database was established
as part of a quality improvement
project centered on the use of a bron-
chiolitis respiratory distress score.
The score was adapted from a score
reported by the Children’s Hospital
and Medical Center of Cincinnati (Fig
1).20 Our modification consisted of
dropping 1 of the original 5 assess-
ment sections for the score, namely,
estimation of an inspiration/expiration
ratio. The protocol specified external
nasal suctioning before scoring and
finding a score of ⱖ3 before proceed-
ing to any type of nebulized therapy.
Use of the scoring system and/or pro-
tocol order set was on a voluntary
basis.
Outcomes
The primary outcomes for this study
were the rate of adverse reactions to
3% saline solution and the methods of
FIGURE 1
Modified Cincinnati bronchiolitis score.
e522 RALSTON et al
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delivery of the therapy (ie, concomi-
tantly with bronchodilators, within 4
hours after bronchodilator adminis-
tration, or alone). We use the phrase
“without adjunctive bronchodilators”
to indicate doses of 3% saline solution
that were administered without pre-
ceding bronchodilator administration
within 4 hours and that did not result
in bronchodilator administration in
the 4 hours immediately after the
dose. For study purposes, adverse re-
actions were defined quite broadly to
include any documented symptom that
was alleged to result from administra-
tion of the nebulized therapy. This
strategy was undertaken deliberately,
to provide the most-liberal assess-
ment of potential adverse effects of
nebulized 3% saline solution, because
the goals of the study were to provide
documentation to support the safety of
a novel therapy. There was no stan-
dardized method of reporting adverse
events in response to nebulized thera-
pies in our center. We created a new
process for respiratory therapy docu-
mentation in the chart in association
with the scoring system used for the
protocol, with addition of a comment
section for each score. Although respi-
ratory therapists documented findings
routinely in our electronic medical
records, the requirement to document
a score was new, as was the immedi-
ate prompt for comments on the
score. We met with the respiratory
therapists regularly during the project,
to promote the scoring system and to
encourage increased documentation.
In general, adverse events are under-
reported in health care settings; there-
fore, we considered it necessary to
take special steps to increase report-
ing during the study period. We did not
provide a definition of an adverse
event to the respiratory therapists, al-
though we encouraged them to docu-
ment any symptoms they thought were
related to the administration of any
nebulized therapy.
RESULTS
One hundred fifty-eight patients met
the inclusion criteria for the study co-
hort. Four patients were excluded, 1
because of chronic lung disease of
prematurity and static encephal-
opathy, 2 because of diagnoses of
bronchopulmonary dysplasia, and 1
because of trisomy 21 with neuromus-
cular impairment, which left 154 pa-
tients constituting the study cohort.
The study cohort is described in Table
1, with reference to any receipt of 3%
saline solution.
Sixty-eight (44%) of 154 patients re-
ceived any 3% saline solution. All doses
of 3% saline solution in the study co-
hort were 4 mL in volume and nebu-
lized with a 6-L flow of oxygen from a
wall source, with the hospital’s stan-
dardized configuration. A total of 444
doses of 3% saline solution were
documented, with a mean of 6.5
doses per patient (median: 4 doses
per patient [interquartile range:
2–10 doses per patient]). Sixty-seven
doses (15%) were administered con-
 ARTICLE

TABLE 1. Characteristics of Patients Who Received Any 3% Saline Solution Versus None terval [CI]: 0.3%–2.8%). One additional
Received 3% Did Not Receive 3% adverse event was documented for a
Saline Solution Saline Solution
dose of 3% saline solution adminis-
(N ⫽ 68) (N ⫽ 86)
Age, mean ⫾ SD, moa 5.2 ⫾ 3.9 7.0 ⫾ 5.2
tered concomitantly with albuterol, for
Male, estimate (95% CI), % 51.5 (39.8–63.0) 54.0 (43.6–64.1) an overall rate of 1.1% (95% CI: 0.4%–
Readmitted within 72 h, estimate (95% CI), % 1.5 (⬍0.01–8.6) 1.2 (⬍0.01–6.8)
Transferred to higher level of care, estimate (95% CI), % 2.9 (0.2–10.7) 2.3 (0.14–8.5)
2.7%) for all doses. All events were re-
Received steroids, estimate (95% CI), % 5.9 (2.9–14.6) 15.1 (8.9–24.3) spiratory in nature, generally were de-
Received antibiotics, estimate (95% CI), % 30.9 (21.1–42.7) 42.0 (32.0–52.4)
Received chest physiotherapy, estimate (95% CI), % 5.9 (1.9–14.6) 2.3 (0.14–8.5)
scribed as coughing, and are fully
Received albuterol, estimate (95% CI), % 20.6 (12.6–31.8) 20.9 (13.6–30.8) characterized in Table 2. With inclusion
Received respiratory scoring protocol, estimate (95% CI), % 61.8 (49.9–72.4) 67.8 (57.4–76.7)
Initial respiratory score, (95% CI)a 1.8 (1.4–2.2) 0.8 (0.6–1.0)
of only events considered significant
Mean respiratory score, (95% CI)a 2.4 (1.9–2.8) 0.9 (0.4–1.2) enough to result in discontinuation of
a P ⬍ .05. the therapy for the remainder of the
hospitalization (2 of 377 doses), the
comitant with or within 4 hours of Four adverse events, all defined as re- adverse event rate was 0.5% (95% CI:
administration of any ␤-adrenergic spiratory in nature, occurred among 0.02%–2%). Finally, with consideration
receptor agonist, with 377 doses 377 doses administered without ad- of only events documented as bron-
(85%) being administered without junctive bronchodilators, for a 1.0% chospasm (the potential adverse ef-
adjunctive bronchodilators. adverse event rate (95% confidence in- fect generating the most concern), the

TABLE 2. Characteristics of Documented Adverse Events With 3% Saline Solution

Age/Gender Type of Event Medication Recorded by Outcome
Administered
6 wk/male Bronchospasm (decreased 4 mL of 3% saline Respiratory therapist Physician was called to bedside by respiratory therapist.
oxygen saturation and solution and physician Predose and postdose respiratory scores were 5 and
increased respiratory 6, respectively. Racemic epinephrine was
rate documented) administered and patient’s condition stabilized,
according to physician’s note. Patient was given 1
more dose of 3% saline with predose respiratory
score of 5, and no additional scores were obtained.
Patient then received scheduled albuterol dose
without improvement. Patient’s condition deteriorated
over next 8 h, with eventual transfer to ICU. Patient
then received scheduled albuterol, epinephrine, and
ipratropium doses and underwent intubation because
of “apnea and respiratory failure” within several
hours after admission to PICU.
2.5 mo/female Coughing during 4 mL of 3% saline Respiratory therapist Dose was discontinued before nebulization was finished,
nebulization solution at discretion of respiratory therapist. Predose
respiratory score was 4; subsequently, scoring was
discontinued and patient was removed from scoring
protocol, at discretion of attending physician (see
below).
2.5 mo/female (same Coughing during 4 mL of 3% saline Respiratory therapist Physician discontinued 3% saline administration after
as above) nebulization solution and second episode of coughing, which reoccurred
2.5 mg of despite addition of albuterol. Patient received
albuterol scheduled albuterol for remainder of hospitalization.
Nursing notes continued to document cough during
and after nebulizations.
4 mo/male Excessive coughing 4 mL of 3% saline Respiratory therapist No intervention was performed. Predose and postdose
solution respiratory scores were 4 and 5, respectively. One
additional dose of 3% saline was given during
hospitalization, without documented adverse event.
Patient was discharged within 24 hours after event.
13 mo/male Excessive coughing 4 mL of 3% saline Respiratory therapist No intervention was performed. No respiratory scores
solution were available. Subsequently, patient was given
scheduled albuterol and 3% saline administration was
discontinued. No further excessive cough during
nebulizations was documented.

PEDIATRICS Volume 126, Number 3, September 2010 e523

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adverse event rate was 0.3% (95% CI:
⬍0.01%–1.6%). All rates are pre-
sented in Table 3.
The bronchiolitis protocol, which al-
lowed us to track respiratory scores,
was used for 98 patients. The institu-
tional bronchiolitis protocol empha-
sized supportive care only, and pa-
tients were required to achieve a
respiratory score at or above an inter-
vention threshold of 3 to receive any-
thing other than nasopharyngeal suc-
tioning and oxygen administration.
Forty-two patients (43%) treated ac-
cording to the protocol received any
3% saline solution. Fifty-6 patients
(57%) did not receive any nebulized
therapies during hospitalization,
which indicates that their respiratory
scores remained ⬍3. Of the total of
444 doses of 3% saline solution, 211
were administered to patients being
treated according to the scoring pro-
tocol, with a mean of 2 doses per pa-
tient (median: 0 doses per patient [in-
terquartile range: 0 –2 doses per
patient]). Of the 211 doses adminis-
tered according to the protocol, only
24 (9%) were administered concomi-
tant with or within 4 hours of a bron-
chodilator. Respiratory scores after
3% saline solution administration im-
proved for 188 (89%) of 211 doses ad-
ministered; however, we do not neces-
sarily interpret this improvement as
resulting from the 3% saline solution,
because additional nasal or nasopha-
ryngeal suctioning and increases in
oxygen delivery also might have
TABLE 3. Adverse Event Rates Associated
With Nebulized 3% Saline Solution
Administered Without Adjunctive
Bronchodilators (N ⫽ 377)
Type of Event Rate, Estimate
(95% CI), %
Any documented event 1.0 (0.3–2.8)
Events resulting in 0.5 (0.02–2)
discontinuation of
therapy
Events characterized 0.3 (⬍0.01–1.6)
as bronchospasm
e524 RALSTON et al
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occurred and we did not attempt to as-
sess systematically the efficacy of the
therapy in this project. Respiratory
scores worsened after 3% saline solu-
tion administration for 2 (1%) of 211
doses administered. Both of these
events, including the scores, are de-
scribed in Table 2.
Respiratory scores, where available,
were different between the patients who
received any 3% saline solution and
those who did not, both on average and
at presentation (Table 1). This is to be
expected, because patients were re-
quired to reach a cutoff respiratory
score before proceeding to any nebu-
lized therapy and patients who re-
ceived any nebulized therapy neces-
sarily would have higher scores. We
also noted a small age difference be-
tween the groups, with the patients in
the 3% saline solution group being
slightly younger. Rates of use of other
therapies, such as antibiotics or ste-
roids, were similar between the 2
groups. Rates of readmission and
transfer to a higher level of care were
equivalent for patients who received
3% saline solution and those who did
not (Table 1).
DISCUSSION
Our study is the first to address directly
the adverse effect profile of 3% saline
solution, used without adjunctive bron-
chodilators, in bronchiolitis. It is notable
that 377 doses of 3% saline solution were
administered without adjunctive bron-
chodilators for 68 patients, with a 1.0%
adverse event rate. Most of our adverse
events were mild and were described as
coughing. Two adverse events (0.5% of
all doses administered) resulted in dis-
continuation of the therapy, and 1 ad-
verse event was classified as bronchos-
pasm and resulted in a physician being
called to evaluate the patient. The physi-
cian who responded to the event docu-
mented stabilization of the patient’s con-
dition after a single dose of racemic
epinephrine. The patient in question pro-
gressed to respiratory failure over the
next 24 hours; however, the documented
reason for intubation was apnea.
One adverse event (3.8% of doses admin-
istered) associated with a dose of race-
mic epinephrine administered ⬍10
minutes after a dose of 3% saline solu-
tion was documented; this involved a
4-month-old patient for whom a physi-
cian was called because of a heart rate
of 189 beats per minute. No interventions
were performed, and the patient experi-
enced an uncomplicated hospitalization,
without administration of any additional
nebulized therapies. This adverse event
was not considered to be related to 3%
saline solution for the purposes of this
study, because no tachycardia or con-
cern regarding tachycardia was docu-
mented before the dose of epinephrine.
One adverse event in response to albu-
terol administered with 3% saline solu-
tion was documented, as detailed in Ta-
ble 2. No adverse reactions to albuterol
alone were found in the available doc-
umentation in our study; however, lit-
erature findings suggest that a de-
crease in oxygen saturation after
administration of albuterol occurs
in bronchiolitis.21 Unfortunately, at-
tempts to quantify oxygen saturation
levels in our database were aban-
doned because too many values were
found to be missing.
The possibility of overreporting of ad-
verse events by respiratory therapists
in our study is likely. As stated previ-
ously, we actively encouraged report-
ing during the study period, through
several methods, and the fact that all
of our adverse events were reported
by respiratory therapists supports the
contention that respiratory therapists
were predisposed to report on the ba-
sis of their involvement in the protocol.
Also, given the fact that the interven-
tion was unblinded, overreporting be-
cause of personal bias regarding the
use of a novel therapy might be more

likely. In addition, the fact that exces-
sive coughing was the most-common
adverse reaction may be questionable,
because cough is encountered fre-
quently with nebulized therapies and
we were unable to provide a standard-
ized definition of excessive coughing.
The possibility of underreporting also
must be considered. If the comments
section was left blank, then this was
interpreted as the absence of an ad-
verse event. Furthermore, patients
who received 3% saline solution and
were not being treated according to
the protocol (n ⫽ 26) did not have the
added oversight of receiving a score
before each dose, which might have
served as a prompt to document ad-
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ARTICLE
verse event rate would be higher if doc-
umentation was incomplete. Finally, be-
cause of our study design, our data
cannot be applied to questions regard-
ing the efficacy of 3% saline solution.
CONCLUSIONS
The use of 3% saline solution without ad-
junctive bronchodilators for young chil-
dren hospitalized with bronchiolitis had
a low rate of adverse events in our cen-
ter. Additional clinical trials of 3% saline
solution in bronchiolitis should evaluate
the effectiveness of 3% saline solution in
the absence of adjunctive bronchodila-
tors, because these medications are not
routinely indicated in bronchiolitis, on
the basis of current evidence.
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e525
Nebulized Hypertonic Saline Without Adjunctive Bronchodilators for Children
With Bronchiolitis
Shawn Ralston, Vanessa Hill and Marissa Martinez
Pediatrics 2010;126;e520; originally published online August 16, 2010;
DOI: 10.1542/peds.2009-3105
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