Redback Spider Antivenom Evaluation II Study (RAVE II Study)

Phase 3

Completed

• Conditions: Redback spiderbite; Injuries and Accidents - Other injuries and accidents; Injuries and Accidents - Poisoning

• Registration Number: ACTRN12609000063213
• Lead Sponsor: Calvary Mater Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.A definite or likely redback spider bite according to either of the following criteria:
a.The spider causing the bite was clearly identified by the patient or clinician, OR
b.A clinical syndrome consistent with typical redback spider envenoming, that is the sensation of a bite followed by two or more of:
1. increasing pain over the first hour
2. radiating, regional or generalised pain
3. local or regional diaphoresis

AND

2.The treating clinician would normally treat the patient with antivenom, namely either for:
1. moderate envenoming = moderate to severe local pain without systemic envenoming, or;
2. severe envenoming = moderate to severe local pain and systemic features

Exclusion Criteria

1.Patients who have received antivenom for this envenoming prior to enrolment
2.Children aged <8 years because of unreliability of the Verbal Numerical Rating Scale for assessment of pain in this group
3.Presentation to hospital >36 hours after the bite

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A clinically significant reduction in severity of pain using the verbal numeric rating scale (VNRS). A clinically significant change in the VNRS will be dependent on the baseline VRNS and defined as a change of 2 or greater for baseline score of 0 to 3, greater than 3 for baseline score of 4 to 6, and 5 or greater for baseline score of 7 to 10. This is based on the definition of Bird and Dickson for visual analogue scales.[2 hours after the commencement of the trial medication];Resolution of systemic effects in patients presenting with systemic envenoming. Systemic envenoming is defined as the presence of 3 of the following: nausea, vomiting, headache, lethargy, malaise and abdominal pain. This outcome will be assessed using clinical history and examination.[2 hours after the commencement of the trial medication]