Background: Each year almost 700 000 deaths occur worldwide due to acute diarrhoeal illness. Emesis in children with acute diarrheal illness is a significant deterrent to Oral Rehydration Therapy (ORT). An effective anti-emetic can thus improve ORT and reduce the need for intravenous (IV) rehydration and hospitalisation. Ondansetron has been shown to significantly reduce IV rehydration and admission in children with acute diarrhoeal illness. No African data exist on the use of ondansetron in acute diarrhoeal illness.
Objectives: The primary objective was to determine the effect of ondansetron in reducing IV rehydration and hospitalisation in children with acute diarrhoeal illness. The secondary objective was to compare persistence of vomiting and diarrhoea after administration of ondansetron.
Methods: This was a parallel randomised double-blinded placebo-controlled trial. Children between 6 and 59 months presenting with some dehydration and vomiting in an acute diarrhoeal illness were enrolled. In addition to standard treatment subjects were randomised to receive either ondansetron or placebo. Subjects were monitored for ORT failure and admission for IV rehydration, and for 48 hours thereafter for persistence of vomiting and diarrhoea. Relative risks and 95% confidence intervals were used for categorical data while means and standard deviation were used for continuous data.
Results: The subjects that failed ORT and required hospitalisation was 18% less in the ondansetron group versus placebo, i.e. RR = 0.17 (95% CI 0.04 - 0.73), P value <0.01. Children who received ondansetron versus placebo had significantly less emesis i.e. 0.7 vs. 1.4 mean episodes during ORT and 0.25 vs. 0.52 mean episodes at 24 hours follow up. The proportion of children with cessation of vomiting during ORT was also higher in the ondansetron group (51.6%) compared to placebo (27.9%). There was no difference in the diarrhoeal episodes between the two groups for up to 48 hours later. (Figure 1)
Conclusions: In children with an acute diarrhoeal illness that failed ORT due to emesis, the proportion admitted for IV hydration was smaller in those who had received ondansetron versus placebo.