In Iran, scorpion Antivenin is injected to all scorpion bitten patients. Antivenin of Scorpion has serious short (anaphylaxis) and long (serum sickness) complications. We want to compare the efficacy of scorpion antivenin and placebo. All patients with scorpion biting will be included in the study and patients with severe symptoms will be excluded. Target sample size is 432. Patients are randomly assigned to receive Antivenin or placebo. Primary outcomes are anaphylaxis reaction, improvement of symptoms and lab data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812142337N2
Registration date:2010-03-05, 1388/12/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-03-05, 1388/12/14
Registrant information
Name
Mani Mofidi
Name of organization / entity
Iran Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 8098
Email address
mofidim@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of antivenin and placebo effectiveness in scorpion biting
Public title
Comparison of antivenin and placebo effectiveness in scorpion biting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: scorpion biting
Exclusion criteria: critically ill patients (shock, life threatening manifestations of scorpion biting)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
432
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
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Expway.
City
Tehran
Postal code
Approval date
2010-02-04, 1388/11/15
Ethics committee reference number
872
Health conditions studied
1
Description of health condition studied
Scorpion bite
ICD-10 code
T63.2
ICD-10 code description
Venom of scorpion
Primary outcomes
1
Description
Anaphylaxy
Timepoint
every 10 minute
Method of measurement
vital signs
2
Description
Improvement of symptoms
Timepoint
every 4 hours
Method of measurement
clinical presentation
3
Description
Adverse effects
Timepoint
every 4 hours
Method of measurement
blood and urine samples
Secondary outcomes
1
Description
Serum sickness
Timepoint
During 1 week after injection of antivenom
Method of measurement
Physical examination and Fever
Intervention groups
1
Description
Injection of a vial of placebo with identical shape as active antivenom
Category
Placebo
2
Description
Injection of a single dose of antivenin, a vial
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz University of Medical Sciences
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Mrs Hosseinmardi
Street address
Iran University of Medical Sciences, Hemmat Expway
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