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Improving Safety of Antivenom in People Bitten by Snakes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00270777
First Posted: December 28, 2005
Last Update Posted: June 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Kelaniya
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00270777     History of Changes
Other Study ID Numbers: 178A07
First Submitted: December 27, 2005
First Posted: December 28, 2005
Last Update Posted: June 5, 2008
Last Verified: June 2008

Keywords provided by University of Kelaniya:
Controlled trial
Snake bite
Safety
Antivenom

Additional relevant MeSH terms:
Snake Bites
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Epinephrine
Racepinephrine
Epinephryl borate
Diphenhydramine
Promethazine
Antivenins
Anti-Inflammatory Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics