A randomised double blind placebo controlled trial of the efficacy of prophylactic adrenaline in the prevention of adverse reactions to anti snake venom (ASV)

ISRCTN	ISRCTN18411149
DOI	https://doi.org/10.1186/ISRCTN18411149
Protocol serial number	N/A
Sponsor	Little Flower Hospital and Research Centre (India)
Funder	Little Flower Hospital (India)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Joseph Joseph
Scientific

Little Flower Hospital and Research Centre
Kalady Road
Angamaly Kerala
683572
India

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	That subcutaneous prophylactic adrenaline reduces the number of adverse anti snake venom reactions
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Adrenaline
Primary outcome measure(s)	Level of adverse reactions
Key secondary outcome measure(s)	Severity of reactions
Completion date	01/10/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	250
Key inclusion criteria	1. Snakebite with systemic symptoms 2. Requirement for ASV 3. Consent
Key exclusion criteria	1. Severe atopic diseases such as asthma 2. Acute cardiac conditions 3. Pregnant women and children <15 years
Date of first enrolment	01/10/2005
Date of final enrolment	01/10/2008

Little Flower Hospital and Research Centre

Angamaly Kerala
683572
India

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan