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

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

Drug Information available for: Hydrocortisone acetate Hydrocortisone Epinephrine bitartrate Epinephrine Promethazine hydrochloride Diphenhydramine Promethazine Proctofoam-HC Hydrocortisone hemisuccinate Diphenhydramine citrate Hydrocortamate Hydrocortisone 21-sodium succinate Diphenhydramine hydrochloride Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

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 by University of Kelaniya

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de Silva HA, Pathmeswaran A, Ranasinha CD, Jayamanne S, Samarakoon SB, Hittharage A, Kalupahana R, Ratnatilaka GA, Uluwatthage W, Aronson JK, Armitage JM, Lalloo DG, de Silva HJ. Low-dose adrenaline, promethazine, and hydrocortisone in the prevention of acute adverse reactions to antivenom following snakebite: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 May;8(5):e1000435. Epub 2011 May 10.

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

Keywords provided by University of Kelaniya:

Controlled trial
Snake bite
Safety
Antivenom

Additional relevant MeSH terms:

Snake Bites
Bites and Stings
Poisoning
Substance-Related Disorders
Epinephrine
Diphenhydramine
Promethazine
Antivenins
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012