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Improving Safety of Antivenom in People Bitten by Snakes

This study has been completed.
Sponsor:
Information provided by:
University of Kelaniya
ClinicalTrials.gov Identifier:
NCT00270777
First received: December 27, 2005
Last updated: June 4, 2008
Last verified: June 2008
History of Changes
  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
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:

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):

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
Epinephryl borate
Diphenhydramine
Promethazine
Antivenins
Hydrocortisone-17-butyrate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
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

ClinicalTrials.gov processed this record on May 22, 2013