None listed
Conditions
Brief summary
Redback spider bites are common in Australia and red back spider envenoming (latrodectism) is the commonest significant envenoming in Australia. Redback spider antivenom (RBS AV) is the most frequently used antivenom in Australia. An estimated 5000 redback spider bites are treated with antivenom each year requiring a median of 2 vials of redback spider antivenom and an emergency department or hospital admission. We estimate this costs between $200,000 and $500,000 annually for antivenom and an equivalent amount in hospital costs. Early adverse reactions occur in approximately 4% of cases (40 to 120 patients annually) causing additional risk to the patient and costs to the health care system. Redback antivenom treatment therefore carries a considerable cost and measureable risk. However, despite the wide use of RBS AV and the clinical impression that it is effective, it has never been tested in a placebo randomized controlled trial. The results from our recent randomised controlled trial of intravenous versus intramuscular administration of redback spider antivenom (RAVE I) raise questions about the effectiveness of the antivenom. It is therefore essential to determine whether RBS AV is effective and justifies the costs and risks associated with its use. We propose to determine the effectiveness of RBS AV in a multicentre randomised placebo-controlled trial.
Interventions
Sponsors
Study design
Eligibility
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