Improving Safety of Antivenom in People Bitten by Snakes

Sponsor

University of Kelaniya (Other)

Overall Status

Completed

CT.gov ID

NCT00270777

Collaborator

(none)

1,000

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Snake Bites	Drug: adrenaline, promethazine, hydrocortisone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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 Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

Frequency of severe reactions to antivenom in the first 48 hours []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)