TITLE:
Comparative Efficacy of Nebulized Magnesium Sulphate in
Combination with Beta2
Agonist versus Beta2 Agonist Alone for Managing Acute Severe
Asthma in Children:
A single-Blinded Randomised Clinical Trial
Introduction:
Asthma is a major non communicable disease(NCD),affecting
both children and adults and
its most common chronic disease among children. Inhaled
medication can control asthma
symptoms &allow people with asthma to lead a normal
active life. Most asthma related
deaths occur in low &lower middle income population
where under diagnosis & under
treatment is a challenge.1Magnesium sulphate has been
proposed as a possible additive
treatment in acute asthma & has been shown to be
effective in severe acute asthma when
given intravenously.2It has been shown to relax smooth
muscle by inhibiting calcium ion influx 3
, it also inhibits acetylcholine &histamine release from
cholinergic motor nerve terminals &mast cells 4. Promotes nitric oxide
synthesis 5. Brochodilation & vasodilation is stimulated by Prostacyclin 6.
As magnesium ions have an anti inflammatory role, attenuatingneutrophil
activation in children with asthma 7
Objectives:
1. Evaluate and compare the therapeutic effectiveness of
nebulised magnesium Sulfate
in conjunction with beta 2 agonists against the use of beta2
agonist Alone in the
management of moderate to severe asthma in children.
2. Investigate the safety profile and tolerability of
nebulised magnesium Sulfate when
administered alongside beta2 agonists in the treatment of
moderate to severe asthma
in children.
3. Assess the long term impact of the combined nebulised
magnesium sulphate & beta 2
agonist treatment on the frequency and severity of asthma
exacerbations in children.
study design:
The study is Randomized controlled study involving two
treatment group
The study participants of children age group between 5-18
years of both sex were randomly allocated to two treatment groups
Group A: Magnesium sulphate in addition to Beta 2 agonist
Group B: Beta2 agonist alones, will be conducted in
Chettinad hospital and research institute ,chennai.
sample size:
SPSS (Statistical Package For Social Sciences) version 20. (IBM
SPASS statistics [IBM corp. released 2011] will be used to perform the
statistical analysis total sample size is 94& each group is 47.
study procedure:
All children who meets the inclusion &exclusion criteria
will be taking into the study after taking an informed assent& written
consent from the parents
&participants . Detailed history will be taken & thorough physical
examination will be done.
STUDY METHODOLGY:
The study will be conducted after ethical committee
approval. The eligible participants with
clinical features of asthma will
randomized into
Group A: Magnesium sulphate in addition to Beta 2 agonist
Group B: Beta2 agonist alone by using simple randomization
technique.
Randomisation will be done using a computer generated simple
randomization technique.
Each participant from each group will receive nebulization
of 2.5ml of salbutamol & other group will receive 1ml of mgso4(1ml=50mg) +
3ml of sterile water+1.5 ml of salbutamol nebulization with tight fitting mask.
the nebulization will be given by the investigator or by trained staffs with
8-10 litres of oxygen /minute. Nebulization will be continued till the child
improves symptomatically. participants will receive the standard supportive
treatment, such as supplemental oxygen, maintenance of hydration, and
antipyretics as required. The clinical data (ASS,HR,oxygen saturation with
pulse oximeter& need for supplemental oxygen)will be measured
&recorded.in this study length of hospital stay &improvement in the
asthma severity score will be considered as the primary outcome measure. it
will be calculated as the number of days between the first dose of nebulization
to the time at which the patient fulfilled the study discharge criteria, the
discharge criteria includes child orally feeding well, no need for supplemental
oxygen and intravenous fluids, absence of accessory muscle use or normal
respiratory rate,and oxygen saturation>95% on room air.secondary outcomes
include HR,oxygen saturation with pulse oximeter,need of supplemental oxygen
&adverse events such as tachycardia>200, hypoxia, trembling, drop in
saturation&dry mucosae.
STUDY OUTCOME:
primary outcome measure: it will be calculated as the number
of days between the first dose of nebulization to the time at which the patient
fulfilled the study discharge criteria, the discharge criteria includes child
orally feeding well,no need for supplemental oxygen and intravenous
fluids,absence of accessory muscle use or normal respiratory rate,and oxygen
saturation>95% on room air.
secondary outcomes: include HR,oxygen saturation with pulse
oximeter,need of supplemental oxygen &adverse events such as
tachycardia>200, hypoxia,trembling,drop in saturation&dry mucosae.
Ethical consideration:
once the child is clinically diagnosed with acute severe
asthma, the parents will be explained regarding usage of mgso4 or salbutamol
nebulization its mechanism of action ,side effects.after getting their informed
written consent , their children will be enrolled in my study to compare the
efficacy of nebulized mgso4 with beta 2 agonist &beta 2 agonist alone.
REFERENCE:
1 Sarhan HA, El-Garhy OH, Ali MA, Youssef NA. The efficacy
of nebulized magnesium
sulfate alone and in combination with salbutamol in acute
asthma. Drug design,
development and therapy. 2016 Jun 9:1927-33.
2 Knightly R, Milan SJ, Hughes R, Knoppâ€Sihota JA, Rowe BH,
Normansell R, Powell
C. Inhaled magnesium sulfate in the treatment of acute
asthma. Cochrane Database of
Systematic Reviews. 2017(11).
3 Gourgoulianis KI, Chatziparasidis G, Chatziefthimiou A,
Molyvdas PA. Magnesium as
a relaxing factor of airway smooth muscles. Journal of
aerosol medicine. 2001 Sep
1;14(3):301-7.
4 Del Castillo J, Engbaek L. The nature of the neuromuscular
block produced by
magnesium. The Journal of physiology. 1954 May 5;124(2):370. |