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ISRCTN
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ISRCTN18411149
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ClinicalTrials.gov identifier
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Public title
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A randomised double blind placebo controlled trial of the efficacy of prophylactic adrenaline in the prevention of adverse reactions to anti snake venom (ASV)
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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That subcutaneous prophylactic adrenaline reduces the number of adverse anti snake venom reactions
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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India
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Disease/condition/study domain
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Anaphylactoid or Pyrogenic reactions to anti snake venom
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Participants - inclusion criteria
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1. Snakebite with systemic symptoms
2. Requirement for ASV
3. Consent
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Participants - exclusion criteria
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1. Severe atopic diseases such as asthma
2. Acute cardiac conditions
3. Pregnant women and children <15 years
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Anticipated start date
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01/10/2005
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Anticipated end date
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01/10/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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250
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Interventions
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Subcutaneous Adrenaline will be administered before ASV. Control: Placebo. All outcomes will be monitored.
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Primary outcome measure(s)
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Level of adverse reactions
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Secondary outcome measure(s)
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Severity of reactions
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Sources of funding
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Little Flower Hospital (India)
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Trial website
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Publications
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Contact name
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Dr
Joseph
Joseph
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Address
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Little Flower Hospital and Research Centre
Kalady Road
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City/town
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Angamaly Kerala
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Zip/Postcode
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683572
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Country
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India
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Sponsor
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Little Flower Hospital and Research Centre (India)
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Address
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PB No. 23
Kalady Road
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City/town
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Angamaly Kerala
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Zip/Postcode
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683572
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Country
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India
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Sponsor website:
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http://www.lfsru.org
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Date applied
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20/09/2005
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Last edited
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15/09/2009
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Date ISRCTN assigned
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29/09/2005
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