What is the recommended dosage and treatment duration of domperidone (motility agent) for vomiting in pediatric patients?

Domperidone for Vomiting in Pediatric Patients

Domperidone is not recommended for treating vomiting in pediatric patients with acute gastroenteritis, as high-quality evidence demonstrates it provides no benefit over placebo when combined with oral rehydration therapy. 1

Evidence Against Domperidone Use

The most recent and highest quality evidence comes from a 2019 randomized, double-blind, phase 3 trial specifically designed to evaluate low-dose domperidone (0.25 mg/kg three times daily) in children aged 6 months to 12 years with acute gastroenteritis. 1 This study found:

• No significant difference in vomiting control: 32.0% of domperidone-treated patients versus 33.8% of placebo patients had no vomiting episodes within 48 hours 1
• No benefit for nausea: Among children ≥4 years, 35.7% on domperidone versus 38.6% on placebo had no nausea episodes 1
• The study was terminated early due to futility analysis 1

This contradicts older studies from 1979 that suggested benefit, but those trials had significantly lower methodological quality and smaller sample sizes. 2, 3 The 2019 evidence should take precedence given its superior design, larger population, and recency.

Current Guideline-Recommended Approach

First-Line Management

• Oral rehydration solution (ORS) is the cornerstone of treatment for vomiting in children with acute gastroenteritis 4, 5
• Administer ORS in small, frequent volumes (e.g., 5 mL every minute initially) 6
• Replace each vomiting episode with approximately 10 mL/kg of ORS 4
• Continue breastfeeding on demand or full-strength formula 6, 4

Antiemetic Considerations When ORS Fails

Ondansetron is the only antiemetic with guideline support for pediatric vomiting:

• Dosing: 0.15 mg/kg per dose (maximum 4 mg) 5, 7
• Indications: Children >4 years with significant vomiting that prevents oral rehydration 4, 5
• Route: Oral or parenteral 7
• Evidence level: Weak recommendation, moderate evidence 4

Important Caveats

• Antiemetics are not a substitute for fluid and electrolyte therapy 4
• The American Academy of Pediatrics does not recommend routine antiemetic use in children <4 years 4
• Ondansetron should only be considered after adequate hydration attempts 4

Why Domperidone Should Be Avoided

Beyond lack of efficacy, domperidone carries regulatory concerns:

• Current authorization restricts use to children >12 years only for short-term relief of nausea and vomiting 8
• Use in younger children is off-label 8
• The European Medicines Agency specifically requested the 2019 study due to safety concerns, which then demonstrated no efficacy 1
• No deaths or serious adverse events occurred in the 2019 trial, but the lack of benefit makes any risk unacceptable 1

Clinical Algorithm for Pediatric Vomiting

1. Assess for red flags: bilious/bloody vomiting, altered mental status, severe dehydration, toxic appearance 7
2. If red flags present: Immediate evaluation for surgical causes, IV fluids, nasogastric decompression if bilious 7
3. If no red flags: Begin ORS in small, frequent volumes 6, 4
4. If vomiting persists despite ORS AND child is >4 years: Consider ondansetron 0.15 mg/kg 5, 7
5. If severe dehydration or ORS failure: Escalate to IV isotonic fluids 4

Domperidone has no role in this algorithm based on current evidence.