Domperidone for Vomiting in Children
Domperidone should NOT be used as first-line treatment for vomiting in children with acute gastroenteritis, as high-quality evidence demonstrates it is no more effective than placebo and ondansetron is the preferred antiemetic when medication is needed. 1
Evidence Against Domperidone
The most recent and highest quality evidence directly addressing this question comes from a 2019 randomized, double-blind, phase 3 trial that was terminated early due to futility. Low-dose domperidone (0.25 mg/kg three times daily) with oral rehydration therapy showed no significant difference from placebo in reducing vomiting episodes (32.0% vs 33.8% with no vomiting) or nausea episodes in children with acute gastroenteritis. 1 This study was specifically conducted at the request of the European Medicines Agency to generate robust safety and efficacy data in children, making it the definitive modern evidence on this topic.
Recommended Antiemetic Approach
First-Line Treatment
- Oral rehydration therapy (ORT) remains the cornerstone of management for gastroenteritis-related vomiting in children, with a recommended dose of 50-100 mL/kg over 3-4 hours for infants and children. 2
- Ondansetron (0.15 mg/kg per dose) should be considered in children >4 years with significant vomiting to facilitate oral rehydration and reduce the need for IV hydration. 2, 3
Evidence Supporting Ondansetron
- Randomized controlled trials demonstrate that ondansetron is efficacious and superior to other antiemetics in treating gastroenteritis-related vomiting, reducing vomiting episodes and facilitating ORT without significant adverse events. 4
- Ondansetron may be prescribed to prevent vomiting and improve tolerance of oral rehydration solutions, potentially reducing hospitalization rates. 3
When Antiemetics Are Indicated
Consider antiemetic therapy when:
- Vomiting is hindering oral rehydration therapy 4
- The child is at risk for dehydration due to persistent vomiting 3
- The child is >4 years old (specific recommendation for ondansetron) 2
Chemotherapy-Induced Vomiting Context
The guidelines provided focus on chemotherapy-induced nausea and vomiting, which is a completely different clinical scenario. For pediatric oncology patients:
- 5-HT3 receptor antagonists (ondansetron, granisetron) plus dexamethasone are recommended for moderate-to-high emetic risk chemotherapy. 5
- Dopamine receptor antagonists are mentioned only as rescue therapy for minimal-risk radiation therapy in adults, not as first-line for pediatric gastroenteritis. 5
Historical Context and Current Practice
While older studies from 1979 suggested domperidone might be effective for chronic pediatric vomiting, 6, 7 the 2019 phase 3 trial definitively demonstrates that modern low-dose domperidone protocols do not provide benefit over placebo for acute gastroenteritis. 1 This represents a critical shift in evidence quality—moving from small pilot studies to a large, well-designed randomized controlled trial.
Safety Considerations
The 2019 study found similar safety profiles between domperidone and placebo, with no deaths or adverse events of special interest (extrapyramidal symptoms or QT prolongation) reported. 1 However, lack of efficacy makes safety profile irrelevant when an effective alternative (ondansetron) exists.
Clinical Algorithm
- Assess hydration status using physical examination (skin turgor, mucous membranes, mental status, urine output) 2
- Initiate ORT immediately for mild-to-moderate dehydration 2, 3
- If vomiting prevents ORT and child is >4 years: Add ondansetron 0.15 mg/kg 2, 3
- If severe dehydration or ORT failure: Administer IV isotonic fluids (20 mL/kg over 30 minutes) 2
- Do NOT use domperidone as it provides no benefit over placebo 1