Improving Safety of Antivenom in People Bitten by Snakes - Full Text View

Sponsored by:	University of Kelaniya
Information provided by:	University of Kelaniya
ClinicalTrials.gov Identifier:	NCT00270777

Purpose

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.

Condition	Intervention	Phase
Snake Bites	Drug: adrenaline, promethazine, hydrocortisone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Further study details as provided by University of Kelaniya:

Primary Outcome Measures:

Frequency of severe reactions to antivenom in the first 48 hours

Secondary Outcome Measures:

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

Estimated Enrollment:	1000
Study Start Date:	March 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270777

Locations

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

Sponsors and Collaborators

University of Kelaniya

Investigators

Principal Investigator:

Asita de Silva

University of Kelaniya

More Information

No publications provided

Study ID Numbers:	178A07
Study First Received:	December 27, 2005
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00270777 History of Changes
Health Authority:	Sri Lanka: Ministry of Healthcare & Nutrition

Keywords provided by University of Kelaniya:

Controlled trial
Snake bite
Safety
Antivenom

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Hydrocortisone
Adrenergic Agents
Immunologic Factors
Anesthetics
Antiemetics
Disorders of Environmental Origin
Adrenergic Agonists
Promethazine
Hypnotics and Sedatives
Vasoconstrictor Agents
Antipruritics
Bites and Stings
Epinephrine

Antivenins
Adrenergic alpha-Agonists
Cortisol succinate
Adrenergic beta-Agonists
Poisoning
Central Nervous System Depressants
Anti-Asthmatic Agents
Anti-Allergic Agents
Cardiovascular Agents
Anesthetics, Local
Histamine
Mydriatics
Histamine Antagonists
Histamine phosphate
Histamine H1 Antagonists

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Hydrocortisone
Immunologic Factors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Antiemetics
Disorders of Environmental Origin
Adrenergic Agonists
Promethazine
Sensory System Agents
Therapeutic Uses

Hypnotics and Sedatives
Vasoconstrictor Agents
Antipruritics
Bites and Stings
Epinephrine
Dermatologic Agents
Antivenins
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Cortisol succinate
Sympathomimetics
Gastrointestinal Agents
Poisoning
Central Nervous System Depressants
Histamine Agents

ClinicalTrials.gov processed this record on July 02, 2009