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

December 27, 2005
June 4, 2008
March 2005
April 2008   (final data collection date for primary outcome measure)
Frequency of severe reactions to antivenom in the first 48 hours
Any acute reaction to antivenom (mild, moderate, or severe) in the first 48 hours
Complete list of historical versions of study NCT00270777 on ClinicalTrials.gov Archive Site
Frequency of moderate & severe reactions to antivenom in the first 48 hours
Not Provided
Not Provided
Not Provided
 
Improving Safety of Antivenom in People Bitten by Snakes
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Snake Bites
Drug: adrenaline, promethazine, hydrocortisone
Not Provided
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. doi: 10.1371/journal.pmed.1000435. Epub 2011 May 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
April 2008
April 2008   (final data collection date for primary outcome measure)

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)
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sri Lanka
 
NCT00270777
178A07
Yes
Not Provided
University of Kelaniya
Not Provided
Principal Investigator: Asita de Silva University of Kelaniya
University of Kelaniya
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP