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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: SLCTR
Last refreshed on: 27 April 2013
Main ID:  SLCTR/2007/005
Date of registration: 18/05/2007
Primary sponsor: IRQUE Project
Public title: Study on infusion rate of snake antivenom therapy
Scientific title: Study on infusion rate of snake antivenom therapy
Date of first enrolment: 1/1/2007
Target sample size: 206
Recruitment status: Completed
URL:  http://www.slctr.lk/trial_details.asp?reg_id={335A0FAE-FDE8-4FC7-B43F-357B500F7EEA}
Study type:  Interventional
Study design:  Randomized controlled clinical trial  
Countries of recruitment
Sri Lanka
Contacts
Name: Dr. Ariaranee Gnanathasan 
Address:  Department of Clinical Medicine, Faculty of Medicine, University of Colombo
Telephone: +94(0)112689188
Email: ariaranee2000@yahoo.com
Affiliation:  Senior Lecturer
Name: Dr. R.M.S.H. Karunatilake 
Address:  General Hospital, Chilaw
Telephone: + 94(0)714348453
Email: sunyalharindra@yahoo.com
Affiliation:  Consultant Physician
Key inclusion & exclusion criteria
Inclusion criteria: Patients with a possible clinical diagnosis of a snakebite
Exclusion criteria: * Under 14 years of age * Pregnant ladies * Previous administration of antivenom * Refusal of consent

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Snakebites requiring antivenom administration
Intervention(s)
Patients will be randomly allocated to two groups and one will receive antivenom dose over 20 minutes while the others will receive the same dose over 2 hours.
Primary Outcome(s)
Proportion with severe systemic allergic reactions within 4 hours of commencement of antivenom
Secondary Outcome(s)
* Proportion with elevated mast cell tryptase
* Proportion with elevated antivenom specific IgE
* Hospital length of stay
* Proportion with mild allergic reactions
* Proportion with delayed administration of -further antivenom therapy
* Proportion developing serum sickness
Secondary ID(s)
Nil known
Source(s) of Monetary Support
IRQUE project C1A2 MBBS SPQEF Grant
Secondary Sponsor(s)
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