What is the first‑line proton pump inhibitor (PPI) for children with documented acid‑related disorders such as gastro‑oesophageal reflux disease or peptic ulcer?

Best PPI in Pediatric Population

Omeprazole is the first-line proton pump inhibitor for children aged 2 years and older with documented acid-related disorders such as GERD or peptic ulcer disease. 1, 2, 3

Regulatory Approval and Dosing

Omeprazole has the strongest FDA approval profile for pediatric use:

• FDA-approved for children 2-16 years at dosages of 0.7-3.3 mg/kg/day for treatment of symptomatic GERD and erosive esophagitis 2, 3
• Available as sprinkle capsules that can be opened and mixed with soft foods, facilitating administration in young children 2
• Initial dosing of 1 mg/kg/day is most consistently reported to heal esophagitis and provide symptom relief 4
• Should be administered approximately 30 minutes before meals for optimal acid suppression 2, 5

Comparative Efficacy

Omeprazole demonstrates superior efficacy compared to H2-receptor antagonists:

• More effective than famotidine and ranitidine for both symptom relief and healing rates of erosive esophagitis in children 2
• Effective for severe esophagitis and cases refractory to H2-receptor antagonists 2
• Clinical trials support efficacy at dosages ranging from 0.2-3.5 mg/kg/day for periods of 14 days to 36 months 4

Treatment Algorithm

Step 1: Confirm indication for PPI therapy

• Document clear gastrointestinal symptoms: heartburn, epigastric pain, recurrent regurgitation, or endoscopically-proven erosive esophagitis 5
• Rule out red-flag signs (bilious vomiting, GI bleeding, forceful vomiting, fever, abdominal distension) that require immediate evaluation 2
• Exclude physiologic "happy spitters" who are thriving without complications 2

Step 2: Initiate omeprazole therapy

• For moderate to severe GERD or erosive esophagitis: Start omeprazole 0.7-1 mg/kg/day once daily 2
• For refractory cases: Increase dose up to 3.3 mg/kg/day if partial response to initial dose 2
• Combine with lifestyle modifications: dietary changes (limit fat <45g/24h, avoid coffee, tea, soda, chocolate, citrus, tomatoes), elevate head of bed, avoid tight clothing 5

Step 3: Treatment duration and monitoring

• Initial treatment course: 4-8 weeks 5, 3
• If inadequate response after 8 weeks, may extend an additional 4 weeks 3
• For recurrent symptoms after healing, additional 4-8 week courses may be considered 3
• Maximum initial evaluation period: 8-12 weeks before considering referral to pediatric gastroenterology 5

Alternative PPIs

If omeprazole is unavailable or not tolerated:

• Lansoprazole: 0.73-1.66 mg/kg/day (maximum 30 mg/day), FDA-approved alternative with similar efficacy 5, 6
• Esomeprazole: 10-20 mg once daily based on weight, FDA-approved for pediatric use 5

Critical Safety Considerations

Age-specific contraindications:

• Do NOT use omeprazole in infants <1 year of age - studies show no benefit over placebo while significantly increasing serious adverse events, particularly lower respiratory tract infections (OR 6.56; 95% CI 1.18-26.25) 7
• For infants requiring pharmacotherapy, H2-receptor antagonists (famotidine 1 mg/kg/day divided twice daily) are preferred 7

Long-term safety concerns:

• Prolonged PPI use (>2.5 years) may cause enterochromaffin cell hyperplasia in up to 50% of children 2, 5
• Associated with increased risk of lower respiratory tract infections, vitamin B12 deficiency, and bone fractures 5
• Limit treatment duration and reassess need for continued therapy regularly 5

Common Pitfalls to Avoid

• Do not use PPIs for chronic cough or respiratory symptoms alone without typical GERD symptoms (heartburn, regurgitation, epigastric pain) 5
• Do not combine H2-receptor antagonists with PPIs in initial therapy - no evidence supports improved outcomes and increases medication burden 2
• Do not prescribe empirically for "silent reflux" without documented gastrointestinal complaints 5
• Do not delay appropriate evaluation in children with warning signs (poor weight gain, recurrent vomiting, dysphagia, GI bleeding) 2, 5

When to Refer to Pediatric Gastroenterology

• Symptoms remain refractory despite 8-12 weeks of optimized omeprazole therapy 5
• Presence of alarm symptoms: dysphagia, weight loss, GI bleeding 5
• Need for endoscopic evaluation to confirm diagnosis or assess complications 1