Improving Safety of Antivenom in People Bitten by Snakes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Snake Bites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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adrenaline, promethazine, hydrocortisone

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No