Comparison of nebulized magnesium sulfate with placebo in the management of patients with moderate to severe acute asthma attack presented to the emergency department
The aim of this study is to evaluate the efficacy of nebulized magnesium sulfate in management of moderate to severe asthma attack.In this double blind ,placebo controlled , multicenter randomized clinical trial 50 patients with moderate to severe asthma attack presenting to emergency department of Rasoul Akram, Sina and Firouzgar hospital in Tehran will be included. Patients with renal or liver insuficiency, heart failure and intubated patients will be excluded.
Patients are randomly assigned to two group ( case and control) each one containing 25 patients.
patients in case group will receive 50 mg oral prednisolone, 2.5 mg nebulized salbutamol, 0.5 mg nebulized atrovent and 500 mg nebulized magnesium sulfate each 20 minutes up to 1 hour.
Patients in control group will be the same as case group but instead of magnesium sulfate will receive normal saline as placebo.
In both groups predicted expirator flow rate will be assessed with peak flowmetere at the beginning and each 20 minutes up to 1 hour. hospital admission , subjective dyspnea scale changes and side effects of treatment also will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022412588N1
Registration date:2013-03-18, 1391/12/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-18, 1391/12/28
Registrant information
Name
Seyed hossein Shaker
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 8098
Email address
sh-shaker@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
vise-challenger of research , Tehran University of Medical Sciences .
Expected recruitment start date
2013-03-05, 1391/12/15
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of nebulized magnesium sulfate with placebo in the management of patients with moderate to severe acute asthma attack presented to the emergency department
Public title
Effect of nebulized magnesium sulfate in management of acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients with moderate to sever acute asthma attack presenting to emergency department
Exclusion criteria : age less than 16 and more than 75 ,liver failure, renal failure, heart failure, fever, intubation and who are dissatisfied for trial.
Age
From 16 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences (TUMS)
Street address
Central building of University, Ghods Ave., Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2011-09-07, 1390/06/16
Ethics committee reference number
210/10240/د/90
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J46
ICD-10 code description
Acute severe asthma
Primary outcomes
1
Description
Predicted Peak Expiratory Flow Rate
Timepoint
Before intervention, at 20, 40, 60 minutes after intervention
Method of measurement
Peak Flowmeter
2
Description
Hospitalization
Timepoint
After 1 hour of intervention
Method of measurement
Data will be recorded by blinded emergency resident
Secondary outcomes
1
Description
Severity of dyspnea
Timepoint
Before intervention, and at 20, 40, 60 minutes after intervention
Method of measurement
Subjective dyspnea scale between 0 and 10
2
Description
Complicatins
Timepoint
After 1 hour of intervention
Method of measurement
Data will be recorded by blinded emergency resident
Intervention groups
1
Description
In addition of standard treatment of asthma (50 mg oral prednisolone, 2.5 mg nebulized salbutamol, 0.5 mg nebulized atrovent ), case group will receive 500 mg of nebulized magnesium sulfate (1cc of sulfate 50%) each 20 minutes up to 1 hour.
Category
Treatment - Drugs
2
Description
standard treatment of asthma
(50 mg oral prednisolone, 2.5 mg nebulized salbutamol, 0.5 mg nebulized atrovent ) but instead of nebulized magnesium sulfate will bli receive 1cc of nebulized normal saline each 20 minutes up to 1 hour as placebo.