This study is a double blind, clinical trial that evaluates the effects of injective dexamethasone associated with anti venum in decrease of limb edema in snake bite patients referring to Razi hospital in Ahvaz after 1 year.Entrances criteria are biting during 6 hours before referring and being in upper or lower limbs.Target sample size is 106 cases.The patients randomize, divided in 2 group with 53 cases , interventional and control. The patients in case group, is treated with dexamethasone 0.4 mg/kg/day as TDS addition to national standard treatment. Sterile water is injected addition to national standard treatment in control group. Also injection continues after removing of edema in bite site ,completely. Investigator that doesn’t know about kind of treatment and with use a scaling ….contain normal saline determines water volume displacement in 0, 6, 18 hours ,second day and the final day that removed edema and measures the change of edema. There lated information are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122411873N1
Registration date:2013-05-06, 1392/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-06, 1392/02/16
Registrant information
Name
Amir Mandegar
Name of organization / entity
Ahvaz Jundishapur University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 9539
Email address
mandegar.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medicine Sciences
Expected recruitment start date
2013-03-11, 1391/12/21
Expected recruitment end date
2013-06-11, 1392/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of injective dexamethasone efficacy associate with anti venum in decrease of limb edema in snake bite patients
Public title
Efficacy of dexamethasone in decrease of limb edema in snake bite patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 1)6 hours from bite, 2)Bite in distal of limbs
Exclusion criteria : 1)Recieved antivenum before admission, 2)Underlying disease such as : hypertension, peptic ulcer, heart failure, active infection (e.g. varicella, tuberculosis), psychosis, diabetes, glucoma, osteoprosis and other conditions of corticosteroid's contraindications, 3)Recieved any glucocorticoid or NSAIDS drugs 4)Pregnancy and lactation
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
61357-15794
Approval date
2013-03-10, 1391/12/20
Ethics committee reference number
ETA-704
Health conditions studied
1
Description of health condition studied
Snake bite
ICD-10 code
T63.0
ICD-10 code description
Snake venom
Primary outcomes
1
Description
Limb edema
Timepoint
At the admission, 6 hours later, 12 hours later, 18 hours later, second day, third day, other days if admission lenght
Method of measurement
volume of limb according to shift of water in a dish scale in ml
Secondary outcomes
1
Description
Decrease of limb edema
Timepoint
Each 6 hours within the first day of admission and then daily until disapearance of edema
Method of measurement
Immersion of limb in to the scaled dish of normal saline and determination of volume based on ml.
Intervention groups
1
Description
Dexamethasone ampul 0.4mg/kg in 3 devided doses every 8 hours daily till recovery of inflammation
Category
Treatment - Drugs
2
Description
Sterile water (with an equal volume of 0.4 mg/kg from dexamethasone)in 3 devided doses every 8 hours during admission.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Ahmad Ghorbani,MD
Street address
Felestin Blv.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Ahvaz JondyShapor University of Medical Sciences
Full name of responsible person
Feghhi,MD
Street address
Esfand St, Golestan Blv.
City
Ahvaz
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,Ahvaz JondyShapor University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research,Ahvaz JondyShapor University of Medical Sciences
Full name of responsible person
Feghhi,MD
Street address
Golestan Blv.
City
Ahvaz
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,Ahvaz JondyShapor University of Medical Sciences
Proportion provided by this source
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
Ahvaz Jundyshapor University of Medical Sciences
Full name of responsible person
Ahmad Ghorbani,MD
Position
Toxicologist
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
61357-33118
Phone
+98 61137430019
Fax
+98 61 1374 3030
Email
mandegar.a@ajums.ac.ir
Web page address
hgolestan.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali Reza Mozaffari,MD
Position
Internal medicine
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
61357-33118
Phone
+98 61137430019
Fax
+98 61 1374 3030
Email
mandegar.a@ajums.ac.ir
Web page address
hgolestan.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Amir Mandegar,MD
Position
Resident of Internal medicine
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
61357-33118
Phone
+98 61137430019
Fax
+98 61 1374 3030
Email
mandegar.a@ajums.ac.ir
Web page address
hgolestan.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)