drugset / Trial / NCT01050270

Scottish and Newcastle Anti-emetic Pre-treatment for Paracetamol Poisoning Study (SNAP)

NCT01050270

RandomizedFactorialQuadruple-blindTreatment

Summary

This study is designed to assess the impact of new approaches to therapy for paracetamol poisoning. Standard therapy is currently acetylcysteine by intravenous infusion over 20.25h. This regimen is given to those deemed "at risk" using standard criteria (British National Formulary 200920). It has 3 major problems, adverse events (nausea and vomiting and anaphylactoid reactions), therapy duration and complexity of administration. This study is primarily designed to test the efficacy of prophylactic anti-emetic therapy. It will also provide sufficient experience and data from a modified shortened IV acetylcysteine regimen to adequately design and power a study of the modified regimen as a new treatment for this common poison. Such an approach has a major potential to reduce patient adverse events from acetylcysteine therapy and shorten duration of hospital stay.

Timeline

Start
2010-09
Primary completion
2012-12
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 300 mg/kg Intravenous
Subject Ondansetron Other / unclassified 4 mg Intravenous

Indications