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

NCT01050270 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2013-07-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ondansetron

4mgs iv bolus

DRUG

acetylcysteine

100 mg/kg over 2 hours then 200mg/kg over 10 hours, followed by glucose 5% for 8 hours

DRUG

acetylcysteine

150 mg/kg over 15 mins 50 mg/kg over 4 hours 100 mg/kg over 16 hours

Sponsors & Collaborators

  • NHS Lothian

    collaborator OTHER_GOV

  • Chief Scientist Office of the Scottish Government

    collaborator OTHER_GOV

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Alasdair J Gray · NHS Lothian

  • Harry K Thanacoody · Newcastle Hospitals NHS Foundation Trust

  • Jamie G Cooper · NHS Grampian

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01050270 on ClinicalTrials.gov