Improving Safety of Antivenom in People Bitten by Snakes

Condition(s) targeted: Snake Bites

Intervention: adrenaline, promethazine, hydrocortisone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Kelaniya

Official(s) and/or principal investigator(s):
Asita de Silva, Principal Investigator, Affiliation: University of Kelaniya

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Frequency of severe reactions to antivenom in the first 48 hours

Secondary outcome: Frequency of moderate & severe reactions to antivenom in the first 48 hours

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Clinical Trials Unit, University of Kelaniya, Ragama, Sri Lanka

Starting date: March 2005
Last updated: June 4, 2008