A study of the safety of a Sri Lankan antivenom compared to Indian antivenom in patients with snakebite
Phase 2
- Conditions
- Daboia russelii and Echis carinatus snakebite
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1. History of snake bite with Daboia russelii or Echis carinatus (by clinical manifestations/visual identification of the snake where possible)
2. Evidence of systemic envenomation based on Ministry of Health/Sri Lanka Medical Association guidelines.
Exclusion Criteria
1. <14 years of age
2. Pregnancy
3. Already received antivenom, fresh frozen plasma (FFP), or pre-medication such as adrenaline, hydrocortisone or promethazine at the primary hospital
4. History of allergy to antivenom
5. Inability to give direct or proxy consent (unconscious and unaccompanied by a relative)
6. Presentation more than 8 hours after snake bite.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Early anaphylactic-like reactions (up to 04 hrs) <br><br>i. Mild: pruritus and/or urticarial only <br><br>ii. Severe: Gastrointestinal symptoms (vomiting, diarrhoea, colicky abdominal pain)<br><br>iii. Bronchospasm, or fall in systolic blood pressure below 90 mmHg.<br><br><br><br>2. Early Pyrogenic reactions (upto 4 hours): increase oral temperature 38°C or above with or without rigors <br><br><br><br>3. Late serum sickness type antivenom reactions (2 weeks later): urticarial, pruritus, arthralgia, fever [1. Every 15 minutes during antivenom administration (for upto 1 hour) and every 30 minutes thereafter up to 4 hours.<br><br>2. Every 15 minutes during antivenom administration (for upto 1 hour) and every 30 minutes thereafter up to 4 hours.<br><br>3. 2 weeks after discharge from hospital<br><br><br>]<br>
- Secondary Outcome Measures
Name Time Method