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DOI: 10.1542/peds.2009-3105; originally published online August 16, 2010;2010;126;e520Pediatrics

Shawn Ralston, Vanessa Hill and Marissa Martinez

With BronchiolitisNebulized Hypertonic Saline Without Adjunctive Bronchodilators for Children

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Nebulized Hypertonic Saline Without Adjunctive

Bronchodilators for Children With Bronchiolitis

WHATS KNOWN ON THIS SUBJECT: Multiple studies evaluatednebulized 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 first study to investigate

systematically the risk of bronchospasm or other significant

adverse effects with hypertonic saline solution administered

without bronchodilators for viral bronchiolitis.

abstractOBJECTIVE:The goal was to determine an adverse event rate for neb-

ulized hypertonic saline solution administered without adjunctive

bronchodilators for infants with bronchiolitis.

METHODS:This was a retrospective cohort study of the use of nebu-

lized 3% saline for children2 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 adverseevents 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.Pediatrics2010;126:e520e525

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; andbChristus Santa

Rosa Childrens Hospital, San Antonio, Texas

KEY WORDS

bronchiolitis, therapy, adverse effects, hypertonic saline

solution

ABBREVIATION

CIconfidence interval

Dr Martinezs 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

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: [email protected]

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 financial relationships relevant to this article to disclose.

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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.25 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.912 Evidence suggests that hy-

pertonic saline solution favorably al-

ters mucociliary clearance in both nor-

mal and diseased lungs, in multiple

clinical settings.1316 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

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 hypertonicsaline 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. Ourprimary 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

Childrens 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 Childrens Hospital re-

search office.

Study Setting

The Christus Santa Rosa Childrens

Hospital is an urban, nonprofit, chil-

drens 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 350500 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-

drens Hospital. The time period was

chosen because of the availability ofan 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 thereforewould 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,

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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 Childrens 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 of3 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

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 respiratorytherapists 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 describedin 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 hospitals 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:

210 doses per patient]). Sixty-seven

doses (15%) were administered con-FIGURE 1Modified Cincinnati bronchiolitis score.



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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 defined as re-

spiratory in nature, occurred among

377 doses administered without ad-

junctive bronchodilators, for a 1.0%

adverse event rate (95% confidence in-

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

adverse event was documented for a

dose of 3% saline solution adminis-

tered concomitantly with albuterol, for

an overall rate of 1.1% (95% CI: 0.4%

2.7%) for all doses. All events were re-

spiratory in nature, generally were de-

scribed as coughing, and are fully

characterized in Table 2. With inclusion

of only events considered significant

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 bron-

chospasm (the potential adverse ef-

fect generating the most concern), the

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

Received 3%

Saline Solution

(N 68)

Did Not Receive 3%

Saline Solution

(N 86)

Age, mean SD, moa 5.2 3.9 7.0 5.2

Male, estimate (95% CI), % 51.5 (39.863.0) 54.0 (43.664.1)

Readmitted within 72 h, estimate (95% CI), % 1.5 (0.018.6) 1.2 (0.016.8)

Transferred to higher level of care, estimate (95% CI), % 2.9 (0.210.7) 2.3 (0.148.5)

Received steroids, estimate (95% CI), % 5.9 (2.914.6) 15.1 (8.924.3)Re cei ve d antibiotics , es ti mate (9 5% CI) , % 30 .9 (2 1.1 42 .7 ) 4 2.0 (32 .052 .4)

Received chest physiotherapy, estimate (95% CI), % 5.9 (1.914.6) 2.3 (0.148.5)

Re cei ve d al bute rol, estim ate (9 5% CI), % 20 .6 (1 2.6 31 .8 ) 2 0.9 (13 .630 .8)

Received respiratory scoring protocol, estimate (95% CI), % 61.8 (49.972.4) 67.8 (57.476.7)

Initial respiratory score, (95% CI)a 1 .8 (1 .42 .2) 0.8 (0.6 1 .0)

Mean respiratory score, (95% CI)a 2 .4 (1 .92 .8) 0.9 (0.4 1 .2)

a P .05.

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

Age/Gender Type of Event Medication

Administered

Recorded by Outcome

6 wk /male Bronc hos pasm (dec re as ed

oxygen saturation and

increased respiratory

rate documented)

4 mL of 3% saline

solution

Respiratory therapist

and physician

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 dosewithout 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.

2.5 mo/female Coug hing during

nebulization

4 mL of 3% saline

solution

Respiratory therapist Dose was discontinued before nebulization was finished,

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

as above)

Coughing during

nebulization

4 mL of 3% saline

solution and

2.5 mg ofalbuterol

Respiratory therapist Physician discontinued 3% saline administration after

second episode of coughing, which reoccurred

despite addition of albuterol. Patient receivedscheduled 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

solution

Respiratory therapist 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.

13 mo/male Excessive coughing 4 mL of 3% saline

solution

Respiratory therapist 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.

ARTICLE



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adverse event rate was 0.3% (95% CI:

0.01%1.6%). All rates are pre-

sentedin Table3.

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

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-scribedin Table2.

Respiratory scores, where available,

weredifferent between the patientswho

received any 3% saline solution and

those who did not, both on average and

at presentation (Table1). 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 didnot (Table1).

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

that377 doses of 3% salinesolution were

administered without adjunctive bron-

chodilators for 68 patients, with a 1.0%

adverse event rate. Most of our adverseevents 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 patients 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 189beats perminute.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 thisstudy, 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 detailedin 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 afteradministration 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, throughseveral 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

TABLE 3. Adverse Event Rates AssociatedWith Nebulized 3% Saline Solution

Administered Without Adjunctive

Bronchodilators (N 377)

Type of Event Rate, Estimate

(95% CI), %

A ny do cumented event 1.0 (0.32.8)

Events resulting in

discontinuation of

therapy

0.5 (0.022)

Events characterized

as bronchospasm

0.3 (0.011.6)



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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-

verse events. However, each of those

charts was carefully reviewed for any

respiratory therapist documentation

in standard locations, and 1 of the ad-

verse events was identified in this

manner.

Our study clearly is limited by its retro-spective nature, and we might have

missed some doses of hypertonic saline

solution because of incompleteness of

the database, which was generated ret-

rospectively through chart review and

review of pharmacy, respiratory ther-

apy, 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-

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.

CONCLUSIONSThe 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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DOI: 10.1542/peds.2009-3105

; originally published online August 16, 2010;2010;126;e520PediatricsShawn Ralston, Vanessa Hill and Marissa Martinez

With BronchiolitisNebulized Hypertonic Saline Without Adjunctive Bronchodilators for Children

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