Improving Safety of Antivenom in People Bitten by Snakes

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00270777

Enrollment

1000

Registered

2005-12-28

Start date

2005-03-31

Completion date

2008-04-30

Last updated

2008-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Snake Bites

Keywords

Controlled trial, Snake bite, Safety, Antivenom

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.

Interventions

DRUGadrenaline, promethazine, hydrocortisone

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Frequency of severe reactions to antivenom in the first 48 hours	—

Secondary

Measure	Time frame
Frequency of moderate & severe reactions to antivenom in the first 48 hours	—

Countries

Sri Lanka

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026