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
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 |
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.
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sri Lanka | Clinical Trials Unit, University of Kelaniya | Ragama |
Lead Sponsor | Collaborator |
---|---|
University of Kelaniya |
Sri Lanka,
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 |
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