Scottish & Newcastle AntiEmetic PreTreatment in Paracetamol Poisoning
Research type
Research Study
Full title
Scottish and Newcastle Anti-emetic Pre-treatment for Paracetamol Poisoning study (SNAP)
IRAS ID
48066
Contact name
D Nicholas Bateman
Sponsor organisation
NHS Lothian
Eudract number
2009-017800-10
Clinicaltrials.gov Identifier
Research summary
60-70% of patients who require treatment with the antidote acetylcysteine after taking an overdose of paracetamol experience nausea and vomiting. Ondansetron is an effective anti-emetic drug used to prevent post-operative nausea and vomiting. It is unclear whether ondansetron can be used in a similar way to prevent nausea and vomiting in patients receiving acetylcysteine treatment. We therefore wish to investigate the prophylactic use of ondansetron in this study by randomly allocating patients to receive either an anti-emetic drug (ondansetron)or a dummy drug (placebo) before receiving treatment with acetylcysteine. About 15% of patients who are treated with the usual regimen of acetylcysteine over 20.25h develop an allergic (anaphylactoid) reaction. It is thought that this is due to the high concentration of acetylcysteine achieved after the large loading dose given currently. We have devised a new regimen which will provide the same total dose of acetylcysteine in a way that the maximum plasma concentration of acetylcysteine is lower. We anticipate that this may lower the rate of allergic reactions. We will also collect blood samples to identify new markers to confirm the efficacy of the modified regimen. In addition to ondansetron or placebo, patients will also be randomly allocated to receive either the usual 20.25h acetylcysteine treatment or the new 12h acetylcysteine regimen followed by 8h of glucose infusion. This means there will be 4 groups of patients receiving either: 1. ondansetron followed by 20.25h acetylcysteine treatment 2. placebo followed by 20.25h acetylcysteine treatment 3. ondansetron followed by 12h acetylcysteine treatment and 8h of glucose 4. placebo followed by 12h acetylcysteine treatment and 8h of glucose This will provide some initial information about the safety and efficacy of this new regimen which will allow us to plan for a much larger national study.
REC name
Scotland A REC
REC reference
10/MRE00/20
Date of REC Opinion
1 Apr 2010
REC opinion
Favourable Opinion