Improving Safety of Antivenom in People Bitten by Snakes

Snake Bites Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270777
• Other study ID #: 178A07
• Status: Completed
• Phase: Phase 4
• First received: December 27, 2005
• Last updated: June 4, 2008
• Start date: March 2005
• Est. completion date: April 2008

Study information

• Verified date: June 2008
• Source: University of Kelaniya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sri Lanka: Ministry of Healthcare & Nutrition
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Snake Bites

Intervention

Drug:
• adrenaline, promethazine, hydrocortisone

Locations

Country	Name	City	State
Sri Lanka	Clinical Trials Unit, University of Kelaniya	Ragama

Sponsors (1)

Lead Sponsor	Collaborator
University of Kelaniya

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of severe reactions to antivenom in the first 48 hours
Secondary	Frequency of moderate & severe reactions to antivenom in the first 48 hours