Improving Safety of Antivenom in People Bitten by Snakes

Phase 4

Completed

• Conditions: Snake Bites

• Registration Number: NCT00270777
• Lead Sponsor: University of Kelaniya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-12-27
• Study First Submitted QC: 2005-12-27
• Study First Posted: 2005-12-28
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-04
• Last Update Posted: 2008-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Frequency of severe reactions to antivenom in the first 48 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trials Unit, University of Kelaniya; 🇱🇰 Ragama, Sri Lanka