Objectives: Evaluation of effeciveness of nebulized Ketamin in treatment of asthma attack.
Design: Double blind randomized clinical trial
Setting and conduct: 63 patients were put randomly in three groups, First group undergo nebulized Combivent, Second group undergo 25 mg of nebulized Ketamin and Combivent. Third group undergo 50 mg of nebulized Ketamin and Combivent. The patients undergo spirometry and pulse oximetry and check of pulse rate and respiratory rate initially and 30, 60 and 120 minutes later.
Inclusion criteria: 63 patients between 18 and 65 years old in acute asthma attack going to Rasoul Akram , Firoozgar, Haftom Tir hospital, who do not have the exlusion criteria.
Exclusion criteria: patients younger than 18 years old and older than 65 years old; Ischemic heart disease; Pneumothorax; Severe respiratory distress with scyanosis or decreased level of consciousness; Pregnancy.
Interventions: 25 mg of nebulized Ketamin and Combivent; 50 mg of nebulized Ketamin and Combivent; nebulized Combivent.
Main outcome measures: Changes in FEV1 in respirometry, Heart rate, Respiratory rate, Pulse oximetry.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052922468N1
Registration date:2016-04-03, 1395/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-03, 1395/01/15
Registrant information
Name
Mohammadreza Ghassemi
Name of organization / entity
Iran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
ghassemi.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of nebulized Ketamin in treatment of asthma attack.
Public title
Evaluation of effeciveness of nebulized Ketamin in treatment of asthma attack.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 63 patients between 18 and 65 years old in acute asthma attack going to Rasoul Akram , Firoozgar, Haftom Tir hospital, who do not have the exlusion criteria.
Exclusion criteria: patients younger than 18 years old and older than 65 years old; Ischemic heart disease; Pneumothorax; Severe respiratory distress with scyanosis or decreased level of consciousness; Pregnancy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthic commity of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Postal code
1449614535
Approval date
2014-08-10, 1393/05/19
Ethics committee reference number
105/2240/د/93
Health conditions studied
1
Description of health condition studied
Asthma attack
ICD-10 code
J46
ICD-10 code description
اسم حاد شدید
Primary outcomes
1
Description
FEV1
Timepoint
Minutes 0,30,60,120
Method of measurement
By Spirometry
2
Description
Heart rate
Timepoint
Minutes 0, 30, 60, 120.
Method of measurement
Counting heart rate in one minute
3
Description
Respiratory rate
Timepoint
Minutes 0, 30, 60, 120.
Method of measurement
Counting respiratory rate in one minute
Secondary outcomes
1
Description
Change in consiousness
Timepoint
Minutes 0, 30, 60, 120
Method of measurement
physical exam
2
Description
Diplopia
Timepoint
Minutes 0, 30, 60, 120
Method of measurement
physical exam
Intervention groups
1
Description
50 mg of nebulized Ketamine and Combivent is adminestered to the first group.
Category
Treatment - Drugs
2
Description
25 mg of nebulized Ketamin and Combivent is adminestered to the second group.
Category
Treatment - Drugs
3
Description
Nebulized Combivent is adminestered to the third group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Dr.Gelareh Ghaffarpour
Street address
Niayesh st., Sattarkhan st.
City
Tehran
2
Recruitment center
Name of recruitment center
Firuzgar hospital
Full name of responsible person
Dr. Gelareh Ghaffarpour
Street address
valiasr square, Behafarin street.
City
Tehran
3
Recruitment center
Name of recruitment center
Haftom Tir Hospital
Full name of responsible person
Dr.Gelareh Ghaffarpour
Street address
Shahr Rey, Rajaei street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences.
Full name of responsible person
Ms. Hossein Mardi
Street address
Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rasoul Akram hospital
Full name of responsible person
Dr.Gelareh Ghaffarpour
Position
Emergency medicine resident
Other areas of specialty/work
Street address
Niayesh st, Sattarkhan st.
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
gelareh.ghaffarpour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasoul Akram Hospital
Full name of responsible person
Dr.Mani Mofidi
Position
Assistant professor
Other areas of specialty/work
Street address
Niayesh St., Sattarkhan St.
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
manimofidi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasoul Akram hospital
Full name of responsible person
Dr.Gelareh Ghaffarpour
Position
Emergency medicine resident
Other areas of specialty/work
Street address
Niayesh St, Sattarkhan St.
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
gelareh.ghaffarpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)