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
WHATS KNOWN ON THIS SUBJECT: Multiple studies evaluated
nebulized hypertonic saline solution as a therapy for viral
bronchiolitis in young children. However, the available studies
combined hypertonic saline solution with some form of
bronchodilator because of theoretical concerns that hypertonic
saline solution may cause bronchospasm.
WHAT THIS STUDY ADDS: This is the rst study to investigate
systematically the risk of bronchospasm or other signicant
adverse effects with hypertonic saline solution administered
without bronchodilators for viral bronchiolitis.

AUTHORS: Shawn Ralston, MD,a,b Vanessa Hill, MD,a,b and

Marissa Martinez, MDb
aDepartment of Pediatrics, University of Texas Health Science
Center at San Antonio, San Antonio, Texas; and bChristus Santa
Rosa Childrens Hospital, San Antonio, Texas

KEY WORDS
bronchiolitis, therapy, adverse effects, hypertonic saline
solution
ABBREVIATION
CIcondence interval
Dr Martinezs current afliation is QTC Medical Services, San
Antonio, TX.
www.pediatrics.org/cgi/doi/10.1542/peds.2009-3105
doi:10.1542/peds.2009-3105

abstract
OBJECTIVE: The goal was to determine an adverse event rate for nebulized hypertonic saline solution administered without adjunctive
bronchodilators for infants with bronchiolitis.
METHODS: This was a retrospective cohort study of the use of nebulized 3% saline for children 2 years of age who were hospitalized with
the primary diagnosis of bronchiolitis at a single academic medical
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 included respiratory distress scores, timing of the use of bronchodilators in relation to 3% saline solution, transfer to a higher level of care,
and readmission within 72 hours after discharge.

Accepted for publication May 28, 2010

Address correspondence to Shawn Ralston, MD, University of
Texas Health Science Center at San Antonio, Department of
Pediatrics, 7703 Floyd Curl Dr, MSC 7829, San Antonio, TX 78229.
E-mail: ralstons@uthscsa.edu
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright 2010 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have
no nancial relationships relevant to this article to disclose.

RESULTS: A total of 444 total doses of 3% saline solution were administered, 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% condence interval: 0.3%2.8%).
Adverse events were generally mild. One episode of bronchospasm
was documented, for a rate of 0.3% (95% condence interval: 0.01%
1.6%).
CONCLUSIONS: The use of 3% saline solution without adjunctive bronchodilators 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 adjunctive bronchodilators. Pediatrics 2010;126:e520e525

e520

RALSTON et al

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ARTICLE

Viral bronchiolitis is the most-common

reason for hospital admission for infants, accounting for 20% of hospitalizations at 1 year of age.1 Metaanalyses of data on the most-used
therapies, namely, nebulized albuterol
and epinephrine, failed to demonstrate any effect on relevant clinical
outcomes, in comparison with placebo.25 Current clinical practice guidelines do not recommend the routine
use of any medication for bronchiolitis.6 Despite the evidence, use of ineffective therapies for bronchiolitis remains high.7,8
Several studies reported on the use of
nebulized 3% saline solution for infants with bronchiolitis, with the majority reporting substantial benets of
therapy.912 Evidence suggests that hypertonic saline solution favorably alters mucociliary clearance in both normal and diseased lungs, in multiple
clinical settings.1316 Because the
pathophysiologic characteristics of
bronchiolitis primarily involve airway
inammation with increased mucus
production and mucus plugging, it is
logical to think that improved mucociliary clearance would be benecial in
bronchiolitis, although there is only indirect evidence that this is true.
The only signicant adverse effect of
nebulized hypertonic saline solution is
the risk of bronchospasm. Use of nebulized hypertonic saline solution is established in the asthma literature as a
diagnostic test to distinguish individuals with asthma from those without
asthma.17 There is a fairly clear doseresponse relationship for hypertonic
saline solution and bronchospasm in
individuals with asthma.18 Typical concentrations used in studies of individuals 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

typical bronchiolitis do not involve

bronchial smooth muscle hyperresponsiveness, 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 coadministered 3% saline solution with
bronchodilators, medications that are
known to be ineffective in the disease.
In only 1 study was any 3% saline solution administered without concomitant bronchodilator treatment; although only some of the patients in
that study received the medication
without bronchodilators, bronchospasm was not a reported adverse effect.12 No evidence has established
that 3% saline solution induces bronchospasm in infants with bronchiolitis,
but its safety when used without adjunctive 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 information about the use of this new therapy in our center, with a specic aim of
establishing a rate of adverse reactions for 3% saline solution used without adjunctive bronchodilators, to establish the safety of the intervention.

METHODS
Study Design
This was a retrospective cohort study
of infants hospitalized with bronchiolitis between December 15, 2008, and
March 15, 2009, at Christus Santa Rosa
Childrens Hospital. This study qualied for exempt status from the University of Texas Health Science Center at
San Antonio institutional review board
and was approved by the Christus
Santa Rosa Childrens Hospital research ofce.

Study Setting
The Christus Santa Rosa Childrens
Hospital is an urban, nonprot, childrens hospital in San Antonio, Texas
(metropolitan area population of 2 million), which serves a population covered primarily by public insurance
programs. Inpatient pediatric care is
provided by a group of academic pediatric hospitalists employed by the University 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 diagnosis 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 viral bronchiolitis (International Classication of Diseases, Ninth Revision,
code 466.11 or 466.19), and hospitalization on 1 of the 2 medical service
oors at Christus Santa Rosa Childrens Hospital. The time period was
chosen because of the availability of
an extensive database being maintained for an ongoing quality improvement project. The 2 medical
service oors were chosen for the
database because they hospitalized
the vast majority of patients with
bronchiolitis in the hospital, had a
xed capacity from year to year, had
clear admission criteria (ie, no cardiac monitoring), and had stable
nurse/patient ratios and therefore
would provide a stable denominator
with little variation in severity of disease for the quality improvement
project.
Exclusion Criteria
Exclusion criteria were the presence of
complicating underlying illnesses (bronchopulmonary dysplasia or chronic lung
disease, neuromuscular impairment,

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e521

immunodeciency, or congenital heart

disease).
Methods
Information was obtained through review of an existing database documenting all bronchiolitis hospitalizations on the regular medical service
oors. The database was established
as part of a quality improvement
project centered on the use of a bronchiolitis respiratory distress score.
The score was adapted from a score
reported by the Childrens Hospital
and Medical Center of Cincinnati (Fig
1).20 Our modication consisted of
dropping 1 of the original 5 assessment sections for the score, namely,
estimation of an inspiration/expiration
ratio. The protocol specied external
nasal suctioning before scoring and
nding a score of 3 before proceeding to any type of nebulized therapy.
Use of the scoring system and/or protocol 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
Modied Cincinnati bronchiolitis score.

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RALSTON et al

delivery of the therapy (ie, concomitantly with bronchodilators, within 4

hours after bronchodilator administration, or alone). We use the phrase
without adjunctive bronchodilators
to indicate doses of 3% saline solution
that were administered without preceding 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 reactions were dened quite broadly to
include any documented symptom that
was alleged to result from administration of the nebulized therapy. This
strategy was undertaken deliberately,
to provide the most-liberal assessment 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 standardized method of reporting adverse
events in response to nebulized therapies in our center. We created a new
process for respiratory therapy documentation in the chart in association
with the scoring system used for the
protocol, with addition of a comment

section for each score. Although respiratory therapists documented ndings

routinely in our electronic medical
records, the requirement to document
a score was new, as was the immediate 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 underreported in health care settings; therefore, we considered it necessary to
take special steps to increase reporting during the study period. We did not
provide a denition of an adverse
event to the respiratory therapists, although we encouraged them to document any symptoms they thought were
related to the administration of any
nebulized therapy.

RESULTS
One hundred fty-eight patients met
the inclusion criteria for the study cohort. Four patients were excluded, 1
because of chronic lung disease of
prematurity and static encephalopathy, 2 because of diagnoses of
bronchopulmonary dysplasia, and 1
because of trisomy 21 with neuromuscular impairment, which left 154 patients 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 received any 3% saline solution. All doses
of 3% saline solution in the study cohort were 4 mL in volume and nebulized with a 6-L ow of oxygen from a
wall source, with the hospitals standardized conguration. 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:
210 doses per patient]). Sixty-seven
doses (15%) were administered con-

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TABLE 1. Characteristics of Patients Who Received Any 3% Saline Solution Versus None

Age, mean SD, moa

Male, estimate (95% CI), %
Readmitted within 72 h, estimate (95% CI), %
Transferred to higher level of care, estimate (95% CI), %
Received steroids, estimate (95% CI), %
Received antibiotics, estimate (95% CI), %
Received chest physiotherapy, estimate (95% CI), %
Received albuterol, estimate (95% CI), %
Received respiratory scoring protocol, estimate (95% CI), %
Initial respiratory score, (95% CI)a
Mean respiratory score, (95% CI)a
a

Received 3%
Saline Solution
(N 68)
5.2 3.9
51.5 (39.863.0)
1.5 (0.018.6)
2.9 (0.210.7)
5.9 (2.914.6)
30.9 (21.142.7)
5.9 (1.914.6)
20.6 (12.631.8)
61.8 (49.972.4)
1.8 (1.42.2)
2.4 (1.92.8)

Did Not Receive 3%

Saline Solution
(N 86)
7.0 5.2
54.0 (43.664.1)
1.2 (0.016.8)
2.3 (0.148.5)
15.1 (8.924.3)
42.0 (32.052.4)
2.3 (0.148.5)
20.9 (13.630.8)
67.8 (57.476.7)
0.8 (0.61.0)
0.9 (0.41.2)

P .05.

comitant with or within 4 hours of

administration of any -adrenergic
receptor agonist, with 377 doses
(85%) being administered without
adjunctive bronchodilators.

Four adverse events, all dened as respiratory in nature, occurred among

377 doses administered without adjunctive bronchodilators, for a 1.0%
adverse event rate (95% condence in-

terval [CI]: 0.3%2.8%). One additional

adverse event was documented for a
dose of 3% saline solution administered concomitantly with albuterol, for
an overall rate of 1.1% (95% CI: 0.4%
2.7%) for all doses. All events were respiratory in nature, generally were described as coughing, and are fully
characterized in Table 2. With inclusion
of only events considered signicant
enough to result in discontinuation of
the therapy for the remainder of the
hospitalization (2 of 377 doses), the
adverse event rate was 0.5% (95% CI:
0.02%2%). Finally, with consideration
of only events documented as bronchospasm (the potential adverse effect generating the most concern), the

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

Age/Gender

Type of Event

Medication
Administered

Recorded by

Outcome

6 wk/male

Bronchospasm (decreased
oxygen saturation and
increased respiratory
rate documented)

4 mL of 3% saline
solution

Respiratory therapist
and physician

2.5 mo/female

Coughing during
nebulization

4 mL of 3% saline
solution

Respiratory therapist

2.5 mo/female (same

as above)

Coughing during
nebulization

4 mL of 3% saline
solution and
2.5 mg of
albuterol

Respiratory therapist

4 mo/male

Excessive coughing

4 mL of 3% saline
solution

Respiratory therapist

13 mo/male

Excessive coughing

4 mL of 3% saline
solution

Respiratory therapist

Physician was called to bedside by respiratory therapist.

Predose and postdose respiratory scores were 5 and
6, respectively. Racemic epinephrine was
administered and patients condition stabilized,
according to physicians 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. Patients 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.
Dose was discontinued before nebulization was nished,
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).
Physician discontinued 3% saline administration after
second episode of coughing, which reoccurred
despite addition of albuterol. Patient received
scheduled albuterol for remainder of hospitalization.
Nursing notes continued to document cough during
and after nebulizations.
No intervention was performed. Predose and postdose
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.
No intervention was performed. No respiratory scores
were available. Subsequently, patient was given
scheduled albuterol and 3% saline administration was
discontinued. No further excessive cough during
nebulizations was documented.

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e523

adverse event rate was 0.3% (95% CI:

0.01%1.6%). All rates are presented in Table 3.
The bronchiolitis protocol, which allowed us to track respiratory scores,
was used for 98 patients. The institutional bronchiolitis protocol emphasized supportive care only, and patients were required to achieve a
respiratory score at or above an intervention threshold of 3 to receive anything other than nasopharyngeal suctioning and oxygen administration.
Forty-two patients (43%) treated according 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 protocol, with a mean of 2 doses per patient (median: 0 doses per patient [interquartile range: 0 2 doses per
patient]). Of the 211 doses administered according to the protocol, only
24 (9%) were administered concomitant with or within 4 hours of a bronchodilator. Respiratory scores after
3% saline solution administration improved for 188 (89%) of 211 doses administered; however, we do not necessarily interpret this improvement as
resulting from the 3% saline solution,
because additional nasal or nasopharyngeal 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
Any documented event
Events resulting in
discontinuation of
therapy
Events characterized
as bronchospasm

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RALSTON et al

Rate, Estimate
(95% CI), %
1.0 (0.32.8)
0.5 (0.022)

0.3 (0.011.6)

occurred and we did not attempt to assess systematically the efcacy of the
therapy in this project. Respiratory
scores worsened after 3% saline solution administration for 2 (1%) of 211
doses administered. Both of these
events, including the scores, are described 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 required to reach a cutoff respiratory
score before proceeding to any nebulized therapy and patients who received any nebulized therapy necessarily would have higher scores. We
also noted a small age difference between the groups, with the patients in
the 3% saline solution group being
slightly younger. Rates of use of other
therapies, such as antibiotics or steroids, 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 rst to address directly
the adverse effect prole of 3% saline
solution, used without adjunctive bronchodilators, in bronchiolitis. It is notable
that 377 doses of 3% saline solution were
administered without adjunctive bronchodilators 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 discontinuation of the therapy, and 1 adverse event was classied as bronchospasm and resulted in a physician being
called to evaluate the patient. The physician who responded to the event documented stabilization of the patients condition after a single dose of racemic

epinephrine. The patient in question progressed to respiratory failure over the

next 24 hours; however, the documented
reason for intubation was apnea.
One adverse event (3.8% of doses administered) associated with a dose of racemic epinephrine administered 10
minutes after a dose of 3% saline solution was documented; this involved a
4-month-old patient for whom a physician was called because of a heart rate
of 189 beats per minute. No interventions
were performed, and the patient experienced 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 concern regarding tachycardia was documented before the dose of epinephrine.
One adverse event in response to albuterol administered with 3% saline solution was documented, as detailed in Table 2. No adverse reactions to albuterol
alone were found in the available documentation in our study; however, literature ndings suggest that a decrease in oxygen saturation after
administration of albuterol occurs
in bronchiolitis.21 Unfortunately, attempts to quantify oxygen saturation
levels in our database were abandoned because too many values were
found to be missing.
The possibility of overreporting of adverse events by respiratory therapists
in our study is likely. As stated previously, we actively encouraged reporting 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 basis of their involvement in the protocol.
Also, given the fact that the intervention was unblinded, overreporting because of personal bias regarding the
use of a novel therapy might be more

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likely. In addition, the fact that excessive coughing was the most-common
adverse reaction may be questionable,
because cough is encountered frequently with nebulized therapies and
we were unable to provide a standardized denition 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 adverse 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-

verse events. However, each of those

charts was carefully reviewed for any
respiratory therapist documentation
in standard locations, and 1 of the adverse events was identied in this
manner.

verse event rate would be higher if documentation was incomplete. Finally, because of our study design, our data
cannot be applied to questions regarding the efcacy of 3% saline solution.

Our study clearly is limited by its retrospective nature, and we might have
missed some doses of hypertonic saline
solution because of incompleteness of
the database, which was generated retrospectively through chart review and
review of pharmacy, respiratory therapy, and nursing electronic records. We
were able to report only adverse events
that were documented in the physician,
respiratory therapist, or nursing notes,
which leaves the possibility that the ad-

CONCLUSIONS
The use of 3% saline solution without adjunctive bronchodilators for young children hospitalized with bronchiolitis had
a low rate of adverse events in our center. Additional clinical trials of 3% saline
solution in bronchiolitis should evaluate
the effectiveness of 3% saline solution in
the absence of adjunctive bronchodilators, 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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