Asthma
Conditions
Keywords
magnesium sulfate, nebulized, lung function
Brief summary
As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered intravenously in the treatment of the patients with acute severe asthma not responding to conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of intravenous MgSO4 administered is not common in clinical practice, because it's prone to have adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension, decreased tendon reflexes and so on with this treatment. The aerosolised route offers the advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle and lower incidence of side effects when compared to the intravenous route. At present, there are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma in children, and the conclusions are controversial.
Interventions
DRUGMagnesium Sulfate
2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg
0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg
DRUGAlbuterol
0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg
Sponsors
Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* known cases of controlled bronchial asthma * ≧4 years of age * the result was positive after acetylcholine provocation test in follow-up visit
Exclusion criteria
* had received corticosteroids (inhaled or systemic) or β2-agonists or theophyllines before the clinic day * had fever (axillary temperature\>38.5℃) * history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis * history of renal insufficiency and known allergy to acetylcholine, albuterol or magnesium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of lung function after interventions | 10 min and 20 min post-dose | to observe the changes of the lung function indices(FEV1、PEF) at 10 min and 20 min after inhaling magnesium sulfate, albuterol, or combination of magnesium sulfate and albuterol respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effectiveness of nebulized magnesium sulfate alone | 10 min and 20 min post-dose | to observe the changes of the lung function indices(FEV1、PEF) at 10 min and 20 min after inhaling magnesium sulfate alone,and compared it with the patients who was nebulized inhalation albuterol alone. |
| the number of patients with adverse events as a measure of safety and tolerability | 20 min | to observe if any patient appear side effects or adverse effects like nausea, vomiting, hypotension or the change of deep tendon reflexes et al. |
Countries
China
Outcome results
None listed