Improving Safety of Antivenom in People Bitten by Snakes

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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Key information

Conditions

Snake Bites Bites and Stings Chemically-Induced Disorders Poisoning Wounds and Injuries

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Trials Unit, University of Kelaniya

Ragama, Sri Lanka

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

adrenaline, promethazine, hydrocortisone

Drug

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

Sponsors and collaborators

Lead sponsor

University of Kelaniya

Other

Registry information

Official study 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

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Dec 28, 2005
Registry last updated: Jun 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed