Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
That subcutaneous prophylactic adrenaline reduces the number of adverse anti snake venom reactions
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Anaphylactoid or Pyrogenic reactions to anti snake venom
Intervention
Subcutaneous Adrenaline will be administered before ASV. Control: Placebo. All outcomes will be monitored.
Intervention type
Drug
Phase
Not Specified
Drug names
Adrenaline
Primary outcome measure
Level of adverse reactions
Secondary outcome measures
Severity of reactions
Overall trial start date
01/10/2005
Overall trial end date
01/10/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Snakebite with systemic symptoms
2. Requirement for ASV
3. Consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Severe atopic diseases such as asthma
2. Acute cardiac conditions
3. Pregnant women and children <15 years
Recruitment start date
01/10/2005
Recruitment end date
01/10/2008
Locations
Countries of recruitment
India
Trial participating centre
Little Flower Hospital and Research Centre
Angamaly Kerala
683572
India
Sponsor information
Organisation
Little Flower Hospital and Research Centre (India)
Sponsor details
PB No. 23
Kalady Road
Angamaly Kerala
683572
India
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Little Flower Hospital (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list