Improving Safety of Antivenom in People Bitten by Snakes

University of Kelaniya1,000 enrolled

Overview

A study to increase the safety of polyvalent antivenom involving 1000 patients in three centres: low dose adrenaline, promethazine, \& hydrocortisone (alone and in combination) to prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double blind, placebo-controlled trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,000

Conditions

Snake Bites

Interventions

adrenaline, promethazine, hydrocortisoneDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Above 12 years of age * Patients admitted to hospital after snake bite in whom antivenom is indicated * Patients who give informed consent Exclusion Criteria: * Patients who are pregnant or nursing * Patients who are currently taking beta- or alpha-adrenoceptor antagonists, or tricyclic antidepressants * Patients in whom adrenaline may be contraindicated (this may include patients with the following: history of ischaemic heart disease, stroke, uncontrolled hypertension, and tachyarrhythmias)

Locations (1)

Clinical Trials Unit, University of Kelaniya

Ragama, Sri Lanka

Outcomes

Primary Outcomes

Frequency of severe reactions to antivenom in the first 48 hours

Secondary Outcomes

Frequency of moderate & severe reactions to antivenom in the first 48 hours

Data from ClinicalTrials.gov

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