Domperidone Use in Pediatric Patients
Domperidone should NOT be routinely used in children with gastroesophageal reflux disease (GERD) or gastroparesis, as there is insufficient evidence to support its routine use and significant safety concerns exist. 1
Guideline Recommendations Against Routine Use
The American Academy of Pediatrics and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition explicitly state that there is insufficient evidence to support the routine use of any prokinetic agent, including domperidone, for the treatment of GERD in infants or older children. 1
Key Safety Concerns
The FDA has issued black box warnings regarding prokinetic agents due to significant adverse effects, and caution is strongly emphasized when using promoters of gastric emptying and motility in pediatric patients. 1
Adverse effects with prokinetic agents have been reported in 11% to 34% of treated patients, including drowsiness, restlessness, and extrapyramidal reactions. 1
While domperidone is considered to have fewer central nervous system effects compared to metoclopramide (since it does not cross the blood-brain barrier as readily), parenteral administration carries particular risks. 2
Evidence Base for Domperidone
The research evidence for domperidone in pediatric GERD is limited and contradictory:
A 2005 systematic review found no robust evidence of efficacy for domperidone in treating GOR/GERD in young children. The review identified only four randomized controlled trials, with only two older trials showing any clinical benefit. 3
Early studies from 1985 showed symptom improvement and reduced postprandial reflux time with domperidone, but these were small, uncontrolled studies. 4
A 1992 double-blind, placebo-controlled trial found that 4 weeks of domperidone therapy was only minimally effective, reducing only the total number of reflux episodes in the postprandial period but not producing symptomatic improvement or significant changes in other reflux measures. 5
Some patients required more than 4 weeks of therapy to show clinical response, suggesting variable efficacy. 5
Recommended Treatment Approach for Pediatric GERD
First-Line Management (All Pediatric Patients)
Lifestyle modifications are emphasized as first-line therapy in both GER and GERD, whereas medications are explicitly indicated only for patients with GERD (not uncomplicated physiologic reflux). 1
For infants: smaller, more frequent feedings, thickening formula (if formula-fed), trial of maternal elimination diet (if breastfeeding), and upright positioning when awake. 6
For older children and adolescents: dietary modifications, weight loss if overweight, avoiding late meals, and head-of-bed elevation. 1
Pharmacologic Therapy (When Indicated)
When medical therapy is warranted for confirmed GERD, acid suppression with proton pump inhibitors (PPIs) is the preferred approach, as they have demonstrated superior efficacy compared to H2-receptor antagonists. 7, 8
For children 2-16 years with symptomatic GERD: omeprazole 10 mg once daily for weight 10 to <20 kg, or 20 mg once daily for weight ≥20 kg. 7
For severe or refractory GERD in infants under 2 years: starting dose of omeprazole 0.7 mg/kg/day, with potential escalation up to 1.4-2.8 mg/kg/day in divided doses. 7
Important caveat: PPIs should not be used for longer than 4-8 weeks without further evaluation and reassessment. 8
When to Consider Specialist Referral
Patients with intractable symptoms despite appropriate medical therapy should be referred to pediatric gastroenterology. 1, 8
Before considering surgical fundoplication, conditions such as cyclic vomiting, rumination, gastroparesis, and eosinophilic esophagitis must be carefully ruled out. 1
Common Pitfalls to Avoid
Do not prescribe prokinetic agents like domperidone as routine therapy for pediatric GERD given the lack of robust efficacy evidence and significant adverse effect profile. 1, 3
Do not use PPIs for uncomplicated infant reflux or "fussiness" without clear GERD symptoms, as this represents inappropriate prescribing that exposes children to unnecessary risks including lower respiratory tract infections. 1, 6
Do not combine multiple prokinetic agents or combine prokinetics with acid suppression without specialist guidance, as there is no evidence this improves outcomes and increases medication burden. 8
Distinguish between physiologic GER (which requires only conservative management) and GERD (which may warrant pharmacologic therapy), as this distinction is critical to avoid overtreatment. 1