Cost-effectiveness of Oral Ondansetron for Children with Acute Gastroenteritis in Primary Care Out-of-hours Service: A Randomized Controlled Trial

Background: Acute gastroenteritis carries both high medical costs and indirect costs, with a total cost of €77.28 million per year in children under 5 years in the Netherlands. Referral, hospitalization, and parental work absence are the main contributors to these high costs.

Objective: To determine the cost-effectiveness of oral ondansetron added to care-as-usual in comparison to care-as-usual alone in children aged 6 months to 6 years with acute gastroenteritis attending out-of-hours primary care.

Methods: We designed a pragmatic randomized controlled trial with a follow-up of 7 days at three out-of-hours primary care services in the north of the Netherlands. We intended to include children aged 6 months to 6 years with a diagnose of AGE considered to be at increased risk of dehydration. The control group received only care-as-usual, what implied the prescription of oral rehydration therapy. The intervention group received care-as-usual plus oral ondansetron (a single dose of 0.1 mg/kg).

Results: We included 194 children for randomization. One gift of oral ondansetron decreased the proportion of children who continued vomiting within the first 4 hours from 42.9% to 19.5% (OR = 0.4, 95%-CI = 0.2, 0.7, NNT = 4). The total mean costs in the ondansetron group were 31.2% lower compared to the care-as-usual group (means, €488 vs €709). The total incremental mean costs for an additional vomiting free child in the first 4 hours were -€9 (95%-CI = -€41, +€3). The cost effectiveness plane clearly indicated lower costs effect of adding ondansetron to the care-as-usual treatment. Without investing any additional money, the chance that ondansetron is cost-effective is almost 95%.

Conclusion: In addition to being clinically beneficial, the oral administration of a single dose of ondansetron to children with an acute gastroenteritis at an out-of-hours primary care is cost-effective, making it a promising treatment strategy.