Improving Safety of Antivenom in People Bitten by Snakes

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: April 2008

Interventions

  • Drug: adrenaline, promethazine, hydrocortisone

Clinical Trial Outcome Measures

Primary Measures

  • Frequency of severe reactions to antivenom in the first 48 hours

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Kelaniya
  • Overall Official(s)
    • Asita de Silva, Principal Investigator, University of Kelaniya

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