JOURNAL OF TROPICAL PEDIATRICS, VOL. 60, NO.

2, 2014

Effect of Inhaled MgSO4 on FEV1 and PEF in Children with

Asthma Induced by Acetylcholine: A Randomized Controlled
Clinical Trail of 330 Cases
by Y. X. Sun,1 C. H. Gong,2 S. Liu,2 X. P. Yuan,3 L. J. Yin,3 L. Yan,3 T. T. Shi,2 and J. H. Dai3
1
Ministry of Education Key Laboratory of Child Development and Disorders
2
Laboratory of Pulmonary Function Test, Childrens Hospital, Chongqing Medical University
3
Center of Respiratory Disorders, Childrens Hospital, Chongqing Medical University, 400014, Chongqing, China

Correspondence: J. H. Dai, No. 136, 2nd Road of Zhongshan, Yuzhong District, Chongqing, China, 400014.
E-mail <danieljh@163.com>.

Summary
Objectives: To determine the response of nebulized magnesium sulfate on the lung function of acetyl-
choline-induced asthma children.
Methods: Three hundred and thirty children of asthma with positive bronchial provocation test were
randomly divided into three groups: magnesium sulfate, albuterol, and a combination of magnesium
sulfate and albuterol. Lung function was compared between the three groups.
Results: Forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF) as percentage
over predicted at 10 min and 20 min in albuterol and combination group were significantly improved
when compared to magnesium group. The changes in FEV1 and PEF expressed as absolute and per-
centage over predicted was not statistically significant from baseline to 20 min in magnesium, albuterol,
and combination of magnesium sulfate and albuterol. There was no significant adverse effect observed
during the present study.
Conclusion: Nebulized magnesium sulfate alone has a bronchodilatory effect in Ach-induced asthmatic
children. The combination of MgSO4 and albuterol did not has a synergistic effect.

Key words: magnesium sulfate, nebulization, asthma, children, lung function.

Introduction As shown in the 2012 Cochrane Collaboration sys-

Magnesium sulfate (MgSO4) seems to have potential
as an adjunctive medication in asthma [1, 2].
Although its exact dose, route of administration
and use based on severity of asthma is still contro-
versial [35], its clinical use in asthma remains an
interesting topic for further research. Several studies
reported that nebulized MgSO4 in adult patients with
asthma exacerbation resulted in earlier improvement
in clinical signs and symptoms, reduction of hospital-
ization and significant improvement in lung function
[69].
Acknowledgements
The author would like to thank Xia Li and Song Li
for all their help and dedication to the study.
tematic review, most studies were developed for adult
populations [10]. However, the role of MgSO4 in
acute exacerbation of childhood asthma is still un-
clear. Only a few studies of small samples reported
the effect of nebulized MgSO4 in the treatment of
acute asthma in children, and the conclusions were
controversial [3, 10, 11]. At present, there is no clin-
ical trial to observe the effect of nebulized MgSO4 or
its combination with beta2-agonist in children with
asthma after acetylcholine (Ach) provocation test.
Thus, the aim of this study was to observe if neb-
ulized MgSO4 alone could improve lung function in
children with induced asthma after acetylcholine
provocation, and to determine whether the combin-
ation of nebulized MgSO4 and albuterol has a syner-
gistic effect.
Methods

Funding Design
Chongqing Science & Technology Commission This study was a prospective, randomized, con-
[grant number cstc2012jjA0115]. trolled trial and was registered as a clinical trial

The Author [2013]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com 141
doi:10.1093/tropej/fmt099 Advance Access published on 16 December 2013
 Y. X. SUN ET AL.

(NCT01856959) with the US National Library of

Medicine (http://www.clinicaltrials.gov). We con-
ducted the trial at Childrens Hospital of
Chongqing Medical University from November
2011 to March 2013. Randomization was performed
using a computer-generated random number se-
quence and Random Allocation Software Version
1.0 with the help of a statistician.
Patients in follow-up visits were preliminarily en-
rolled for confirmed diagnosis of bronchial asthma,
416 years of age and positive Ach provocation re-
sults in previous tests. Patients were excluded if they
had fever (axillary temperature ^38.5  C), history of
having received corticosteroids (inhaled or systemic),
beta2-agonist, ipratropium or theophylline in the last
3 days, history of chronic diseases like bronchopul-
monary dysplasia or cystic fibrosis, history of renal
insufficiency and known allergy to acetylcholine,
albuterol or MgSO4.
We recorded demographic data which included
age, gender, height and weight as well as the lung FIG. 1. Flow chart showing timing of lung function
function test results. Forced expiratory volume in tests. All children underwent baseline lung function
one second (FEV1) and peak expiratory flow and acetylcholine provocation test, then were rando-
(PEF) were measured using a masterscope com- mized to different groups (magnesium sulfate group
puter controlled lung function machine [M], albuterol group [A] and a combination of mag-
(MasterScreenTM PFT system, Jaeger), and re- nesium sulfate and albuterol [MA] group to
peated after the acetylcholine provocation test and undergo a bronchodilation test using different bron-
at 10 min and 20 min after inhaled different drugs, chodilator agents. Four different doses (0.5 mg/dl,
respectively. 2 mg/dl, 8 mg/dl and 16 mg/dl) of acetylcholine were
After baseline FEV1 and PEF were recorded, all of used, and patients were nebulized for 1 min from low
the children were nebulized Ach in concentration of to high levels of concentration. Lung function tests
0.5, 2, 8, 16 mg/dl for bronchial provocation test by were repeated after every dose, and terminated if
using Pari turbo BOY nebulizer (Pari, Starnberg, EFV1 or PEF decreased by more than 20%.
Germany). Nebulization lasted for 1 min and was Bronchodilator agents administered included a
from low to high concentration gradually in each pa- single dose of 150 mg (2 ml) isotonic magnesium sul-
tient. Lung function tests were carried out after each fate (magnesium sulfate group) or 2.5 mg albuterol
inhalation. The provocation test was terminated once (0.5 ml) mixed with 1.5 ml of normal saline (albuterol
the patients FEV1 and/or PEF decreased by more group) or 2.5 mg (0.5 ml) albuterol mixed with
than 20% from the baseline. After completing the 150 mg (2 ml) magnesium sulfate (combination of
provocation test, 330 patients were finally included magnesium sulfate and albuterol group). These
and randomly divided into 3 groups to receive differ- were nebulized with 810 l/min of oxygen and
ent nebulizations immediately: magnesium sulfate lasted 5 min. The study was terminated if children
group [M] (2 ml of isotonic MgSO4, 286 mOsm/l, showed persistent hypoxia, rough cough or tendinous
7.5% solution, 150 mg), albuterol group [A] (0.5 ml reflex drops. PEF or FEV1 at 20 min after broncho-
dilation test rose above 10% compared to after the
albuterol diluted in 1.5 ml normal saline, 2.5 mg) and
acetylcholine provocation test, then children left, or
combined therapy group [AM] (0.5 ml (2.5 mg)
nebulized necessary albuterol. If we found complica-
albuterol mixed with 2 ml isotonic MgSO4
tions, side effects and adverse effects, the children
(150 mg)). These were nebulized with a mouthpiece
would be given oxygen, albuterol or adrenaline.
and 810 l/min of oxygen with a Pari LCD jet deliv-
ery apparatus (Pat No 022G876B, Pari, Starnberg,
Germany)for 5 min (Fig. 1). The doses and inter-
vention methods of each bronchodilator agents were were treated with oxygen, albuterol, 10% calcium
adopted based on study from Mahajan et al. [12] and gluconate or adrenaline.
were modified by the researchers. In this study, vital signs, oxygen saturation (SpO2)
Patients could go home only when their PEF or by pulse oximetry (Pulse Oximeter N560, Topchance,
FEV1 at 20 min rose over 10% compared to that of China) , wheezing, use of accessory muscle and in-
the post-acetylcholine test. If patients developed ability to speak in complete sentences were measured
complications, side effects or adverse effects, they for each patient before and after each intervention.

142 Journal of Tropical Pediatrics Vol. 60, No. 2

Y. X. SUN ET AL.

Deep tendon jerks were recorded and repeated at
10 min and 20 min after the interventions.
Ethical approval
The study protocol and informed consent form were
approved and followed by the institutional ethics
committee of Childrens Hospital, Chongqing
Medical University and written informed consent
was obtained from all participants and their parents.
Statistical analyses
The SPSS software package v.17 (SPSS Inc.,
Chicago, IL, USA) was used to calculate statistical
inferences. A statistician also advised on the use of
statistical methods.
Results
Three groups did not differ significantly in age, sex,
height, weight, baseline of lung function, dose of Ach
and post-Ach lung function (FEV1 absolute
1.26 l  0.44[M], 1.19 l  0.45[A], 1.23 l  0.49[AM],
p 0.499 and % predicted 103.28%  15.18%[M],
103.79%  13.84%[A], 102.37%  15.12%[AM],
p 0.769. PEF absolute 3.01 l/s  0.96 [M],
2.88 l/s  1.08[A], 2.98 l/s  1.18[AM], p 0.621
and % predicted 99.04%  17.44%[M], 99.14% 
18.02%[A], 98.31%  17.67% [AM], p 0.932.)
(Table 1).
FEV1 and PEF as percentage over predicted at
10 min and 20 min in [A] and [AM] group were sig-
nificantly improved when compared to [M] group
(FEV1, % predicted, 10 min, 97.79%  16.13% vs.
90.37%  14.62%, 95.72%  15.37% vs. 90.37% 
14.62%, respectively, p 0.001. FEV1, % predicted,
20 min, 101.20%  16.70% vs. 96.67%  15.07%,
102.17%  14.79% vs. 96.67%  15.07%, respect-
ively, p 0.021. PEF, % predicted, 10 min,
94.82%  19.13% vs. 87.34%  15.62%, 94.83% 
15.25% vs. 87.34%  15.62%, respectively,
p 0.001. PEF, % predicted, 20 min, 99.39% 
19.31% vs. 93.57%  16.40%, 100.17%  17.47%
vs. 93.57%  16.40%, respectively, p 0.011). But
there was no statistical difference of FEV1 and
PEF as absolute value between three groups
(Tables 2 and 3).
After Ach provocation, FEV1 and PEF as abso-
lute value and percentage over predicted in [M], [A]
and [AM] group were decreased compared to their
baselines. Then at 10 min and 20 min after inhalation
of magnesium sulfate, albuterol and combination of
magnesium sulfate and albuterol, FEV1 and PEF
both expressed as absolute value and percentage
over predicted improved compared to post-Ach.
Only in [M] group, there was a statistical difference
in FEV1 and PEF at 10 min post-Ach expressed as
absolute value and percentage over predicted when
compared to its baseline lung function (FEV1,

TABLE 1
Baseline characteristics of the patients in all three groups

Variable M group (n 110) A group (n 110) A M group (n 110) p-value

Gender (n/%) p 0.394

Male 56 (50.9%) 66 (60.0%) 60 (54.5%)
Female 54 (49.1%) 44 (40.0%) 50 (45.5%)
Age (years) 6.30  2.30 5.77  2.10 6.13  2.32 p 0.205
Height (cm) 117.72  14.47 114.61  13.50 116.46  15.30 p 0.342
Weight (kg) 24.04  8.22 22.53  7.83 23.89  8.88 p 0.499
Ach (mg/dl) 7.48  5.86 7.26  5.95 7.56  6.01 p 0.861
FEV1, baseline (l) 1.26  0.44 1.19  0.45 1.23  0.49 p 0.499
FEV1, % predicted 103.28  15.18 103.79  13.84 102.37  15.12 p 0.769
PEF, baseline (l/s) 3.01  0.96 2.88  1.08 2.98  1.18 p 0.621
PEF (% predicted) 99.04  17.44 99.14  18.02 98.31  17.67 p 0.932
FEV1, post-Ach (l) 0.89  0.31 0.84  0.35 0.86  0.36 p 0.617
FEV1, post-Ach (% predicted) 72.96  14.79 72.39  13.96 71.57  13.03 p 0.758
PEF, post-Ach (l/s) 2.22  0.80 2.14  1.00 2.20  1.00 p 0.806
PEF, post-Ach (% predicted) 72.07  15.35 72.51  19.15 71.92  16.59 p 0.965

Values are mentioned as mean  SD.

M group: magnesium sulfate, A group: albuterol, AM group: albuterolmagnesium sulfate
The numerical data were reported as proportions, which analysed with chi-square test (2) to examine the differences in all
groups between each other, and the statistical significance was set at p-values < 0.05, two-tailed. The quantitative data were
presented as means  SD. Analysis of variance (ANOVA) or rank test was (if the variance is not homogeneous) used to
identify the differences in mean values on quantitative data with repeated measures between the groups and a value of p < 0
.05 was taken as significant, two-tailed.
(FEV1 and PEF represent values after acetylcholine provocation test. FEV1, % predicted and PEF, % predicted represent
the percentage of predicted in FEV1 and PEF, respectively, at different time points.)

Journal of Tropical Pediatrics Vol. 60, No. 2 143

 Y. X. SUN ET AL.

TABLE 2
FEV1 (absolute) and PEF (absolute) after different interventions in three groups

Variable M group (n 110) A group (n 110) A M group (n 110) p-value

FEV1 (l) 10 min 1.10  0.38 1.12  0.42 1.15  0.47 p 0.679
20 min 1.12  0.40 1.16  0.45 1.23  0.48 p 0.533
PEF (l/s) 10 min 2.68  0.87 2.57  1.05 2.87  1.12 p 0.355
20 min 2.87  0.92 2.88  1.07 3.03  1.17 p 0.440

Values are mentioned as mean  SD.

The quantitative data were presented as means  SD. Analysis of variance (ANOVA) or rank test was (if the variance is not
homogeneous) used to identify the differences in mean values on quantitative data with repeated measures between the
groups and a value of p < 0.05 was taken as significant, two-tailed.

TABLE 3
FEV1 and PEF as percent predicted after different interventions in three groups

Variable M group (n 110) A group (n 110) AM group (n 110) p-value

FEV1 (% predicted) 10 min 90.37  14.62 97.79  16.13a 95.72  15.37a p 0.001
20 min 96.67  15.07 101.20  16.70a 102.17  14.79a p 0.021
PEF (% predicted) 10 min 87.34  15.62 94.82  19.13 a 94.83  15.25 a p 0.001
20 min 93.57  16.40 99.39  19.31 a 100.17  17.47 a p 0.011

Values are mentioned as mean  SD.

The quantitative data were presented as means  SD. Analysis of variance (ANOVA) or rank test was (if the variance is not
homogeneous) used to identify the differences in mean values on quantitative data with repeated measures between the
groups and a value of p < 0.05 was taken as significant, two-tailed.
a represents significant difference compared to M group.

absolute, 10 min, 1.10 l  0.38 vs. 1.26 l  0.44,
p 0.000. FEV1, % predicted, 10 min,
90.37%  14.62%, vs. 103.28%  15.18%. PEF, ab-
solute, 10 min, 2.68 l/s  0.87 vs. 3.01 l/s  0.96. PEF,
% predicted, 10 min, 87.34%  15.62% vs.
99.04%  17.44%) (Tables 4 and 5).
The changes in FEV1 and PEF expressed as abso-
lute and percentage over predicted was not statistic-
ally significant from baseline to 20 min in [M], [A]
and [AM] group (Tables 4 and 5).
Only in [M] group, three children had persistent
cough and four childrens PEF or FEV1 increased
<10% at 20 min, but after inhaling albuterol the
lung function recovered to baseline with no obvious
cough or dyspnea. Apart from this none of the pa-
tients in each group showed any other adverse reac-
tions or side effects.
Discussion
The effect of magnesium sulfate administrated intra-
venously in the treatment of acute asthma exacerba-
tion has been demonstrated by a number clinical
trials and systematic reviews [10, 13, 14]. The
Global Initiative for Asthma has mentioned nebu-
lized salbutamol administered in isotonic magnesium
sulfate provides greater benefit than if it is delivered
in normal saline (Evidence A) [15].
However, this conclusion was mainly derived from
the studies in adults and the effect in nebulization
form is controversial [3, 4]. To our knowledge,
there are only a few clinical trails of inhaled
MgSO4 in children with acute asthma attacks [12,
13]. One trail showed that the addition of magnesium
to albuterol seems to provide short-term benefits in
children with acute exacerbations of mild to moder-
ate asthma [12]. Another trail conducted by Meral
et al. [16] comparing albuterol and magnesium as
monotherapy showed that magnesium sulfate neither
improved the lung function nor decreased the admis-
sion rate. Though the importance of MgSO4 in acute
asthma attacks has been demonstrated, there are no
trails looking at the MgSO4 alone and a combination
with beta2-agonist on lung function of children with
asthma induced by Ach.
The present study is the first to investigate the
effect of inhaled MgSO4 on FEV1 and PEF of chil-
dren with asthma induced by Ach. Our results
showed that nebulized MgSO4 has a definite
bronchodilatory effect in asthmatic children with
acetylcholine-induced bronchoconstriction, but the
improvement in FEV1 and PEF was not better
than nebulized albuterol alone either at 10 min or at
20 min. The peak effect of MgSO4 seemed to be at
20 min or over and the effectiveness of

144 Journal of Tropical Pediatrics Vol. 60, No. 2

Y. X. SUN ET AL.

TABLE 4
FEV1 (absolute) and PEF (absolute) at different time points in three groups

Variable Baseline Inhaled Ach 10 min 20 min p-value

FEV1 (l)
M group 1.26  0.44a 0.89  0.31 1.10  0.38a,b 1.18  0.40a P 0.000
A group 1.19  0.45a 0.84  0.35 1.12  0.42a 1.16  0.45a P 0.000
A M group 1.23  0.49a 0.86  0.36 1.15  0.47a 1.22  0.48a P 0.000
PEF (l/s)
M group 3.01  0.96a 2.22  0.80 2.68  0.87a,b 2.87  0.92a P 0.000
A group 2.88  1.09a 2.14  1.00 2.75  1.05a 2.88  1.07a P 0.000
A M group 2.98  1.18a 2.20  1.00 2.87  1.12a 3.03  1.17a P 0.000

Values are mentioned as mean  SD.

The quantitative data were presented as means  SD. Analysis of variance (ANOVA) or rank test was (if the variance is not
homogeneous) used to identify the differences in mean values on quantitative data with repeated measures between the
groups and a value of p < 0.05 was taken as significant, two-tailed.
(a represents significant difference compared to post-acetylcholine in all groups, b represents significant difference between
baseline and 10 min in M group.)

TABLE 5
FEV1 and PEF as percent of predicted at different time points after interventions in three groups

Variable Baseline Inhaled Ach 10 min 20 min

FEV1, (% predicted)
M group 103.28  15.18 72.96  14.79 90.37  14.62a,b 96.67  15.07b
A group 103.79  13.84 72.39  13.96 97.79  16.13a 101.20  16.70a
A M group 102.37  15.12 71.57  13.03 95.72  15.37a 102.17  14.79a,b
PEF (% predicted)
M group 99.04  17.44a 72.07  15.35 87.34  15.62a,b 93.57  16.40a,c
A group 99.14  18.02a 72.51  19.15 94.82  19.13a 99.39  19.31a
A M group 98.31  17.67a 71.92  16.59 94.83  15.25a 100.17  17.47a,c

Values are mentioned as mean  SD.

The quantitative data were presented as means  SD. Analysis of variance (ANOVA) or rank test was (if the variance is not
homogeneous) used to identify the differences in mean values on quantitative data with repeated measures between the
groups and a value of p < 0.05 was taken as significant, two-tailed.
(FEV1, % predicted and PEF, % predicted represent percent of predicted in FEV1 and PEF, respectively. a represents
significant difference compared with M group. b represents significant difference between baseline and 10 min in M group.
c represents significant difference from 10 min to 20 min.)

bronchodilatation gradually increased along with the
extension of time, but this conclusion could not be
confirmed in the present study because we just inves-
tigated the changes of lung function until 20 min after
interventions. In addition, there was no evidence to
support the combination of nebulized MgSO4 and
albuterol had a synergistic effect. But in [AM]
group the percentage over predicted of FEV1 and
PEF at 20 min had a significant improvement when
compared to 10 min, which was not differ in [A]
group. We hypothesize it may be associated with
the increasing effectiveness of magnesium with time.
This requires more studies with a longer duration of
follow-up.
In the present study, we found that FEV1 and
PEF as percentage over predicted but not as
absolute value at 10 min and 20 min in [A] and
[AM] group were significantly improved when
compared to [M] group. As we know, lung func-
tion indices differ not only between the sexes but
also with age and height. FEV1 and PEF ex-
pressed as percentage over predicted seem to be
more useful than absolute values in comparison
of their changes.
There are several factors which influence the effect
of aerosol MgSO4 or its combination therapy with
beta2-agonist such as function of 2 receptor, con-
centration, osomolarity, nebulizer and so on. Firstly,
we evaluated the bronchodilatory effect of nebulized
magnesium through measuring the changes of lung
function by inhaling acetylcholine and then induced
bronchoconstriction in asthmatic children. The

Journal of Tropical Pediatrics Vol. 60, No. 2 145


airway responsiveness, the number and the function
of 2 receptor in those patients were different from
those with acute exacerbation [17]. Therefore, it
cannot completely demonstrate bronchodilatory
effect of nebulized MgSO4 in children with acute
asthma attack. Secondly, pharmacokinetic studies
have shown that the onset time of MgSO4 was not
identical due to different delivery routes. Meral et al.
[16] and Mangat et al. [18] demonstrated that the
effect of nebulized MgSO4 could continue for 1 h.
But we only observed changes of lung function at
10 min and 20 min, which could not accurately de-
scribe the relationship between the bronchodilatory
effect of MgSO4 and its duration of action. Thirdly,
hyperosmolar solutions delivered by a jet nebulizer
might induce bronchoconstriction, so we chose a
7.5% solution of isotomic MgSO4. However, the
osomolarity in [AM] group has changed as the con-
centration of MgSO4 reduced from 7.5% to 6% in
present study, which might affect the synergistic
effect of nebulized albuterol and MgSO4.
Otherwise, the concentration and the dose of
MgSO4 used in our study differed from studies of
Nannini et al. (7.5%, 3 ml) [19], Mahajan et al.
(6.3%, 2.5 ml) [12] and Meral et al. [16] (280 mmol/
l, 2 ml) which might lead to inconsistent conclusions.
Whether there is a doseresponse relationship be-
tween the concentration, dose and effect needs to
be addressed by future studies. We aimed our study
to determine whether a single dose of nebulized
MgSO4 alone has bronchodilatory effect and the
combination of MgSO4 and albuterol has a synergis-
tic effect. In the present study, we could not answer
repeated doses of these agents would be sustainable
in improvement of FEV1 and PEF. Finally, Coates
et al. [20] demonstrated superior performance of
Aeroneb Go/Idehaler system with respect to pulmon-
ary aerosol delivery and optimal particle size while
maintaining acceptable osmolarity. Unlike above stu-
dies, we used 810 l/min of oxygen to deliver each
medication, which might have impact on airway
deposition.
In present study, there were seven patients with
poor response to inhalation of MgSO4. None of the
patients in our study showed any adverse reactions or
side effects, which means the use of nebulized mag-
nesium in children was safe.
Conclusion
The present study showed that nebulized MgSO4
alone has bronchodilatory effect in asthmatic chil-
dren with Ach-induced bronchoconstriction, but the
improvement in FEV1 and PEF was not better than
nebulized albuterol alone. In addition, the synergistic
effect of combination of magnesium sulfate and albu-
terol has not been demonstrated, and the dose
responsetime relationship needs to be explored in
future studies.
146
Y. X. SUN ET AL.
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