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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Wounds and Injuries
Epinephrine
Racepinephrine
Epinephryl borate
Diphenhydramine
Promethazine
Antivenins
Hydrocortisone-17-butyrate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014