From the Guidelines
Metoclopramide is not recommended for the treatment of Gastroesophageal Reflux Disease (GERD) in premature infants due to its significant risk of adverse effects, including extrapyramidal reactions and neurodevelopmental concerns. The use of metoclopramide in infants has been associated with adverse effects in 11% to 34% of patients, as reported in a study published in Pediatrics 1. Although metoclopramide may decrease GERD symptoms, the risks outweigh the benefits, particularly in premature infants with immature neurological systems.
Alternative Treatment Options
Instead of metoclopramide, the following alternatives can be considered:
- Non-pharmacological approaches, such as smaller, more frequent feedings, proper positioning (30-45 degree elevation after feeds), thickened feeds if appropriate, and careful burping
- Histamine-2 receptor antagonists like ranitidine (1-2 mg/kg/dose twice daily) or proton pump inhibitors like esomeprazole (0.5-1 mg/kg/day) if medication is deemed necessary after non-pharmacological measures fail
Rationale for Recommendation
The recommendation against metoclopramide is based on the potential for significant adverse effects, as highlighted in a study published in Pediatrics 1. The study notes that efforts to design a prokinetic agent with benefits that outweigh adverse effects have proven difficult, and metoclopramide has received a black box warning regarding its adverse effects.
Key Considerations
When considering treatment for GERD in premature infants, it is essential to:
- Prioritize non-pharmacological approaches
- Limit treatment duration to 2-4 weeks with reassessment of symptoms
- Carefully monitor for side effects and regularly reassess the need for continued therapy
- Consider the potential risks and benefits of any medication, particularly in premature infants with immature neurological systems, as reported in a study published in Pediatrics 1
From the Research
Efficacy of Metoclopramide for GERD in Premature Infants
- The efficacy of metoclopramide for Gastroesophageal Reflux Disease (GERD) in premature infants has been studied in several research papers 2, 3, 4, 5, 6.
- A randomized clinical trial conducted in 2021 found no clinically significant differences in GERD-related symptoms between premature infants treated with metoclopramide and those treated with a placebo 2.
- Another study published in 2013 reported a case of a premature infant who experienced dystonic reactions after being treated with metoclopramide, highlighting the potential for adverse effects in this population 3.
- A systematic review of metoclopramide for the treatment of GERD in infants, published in 2006, found that the current literature is insufficient to either support or oppose the use of metoclopramide in this population due to marked heterogeneity in patient populations, dosing, and outcomes studied 4.
- A 2012 review of gastroesophageal reflux in preterm infants noted that the efficacy and safety of GERD therapy have not been studied systematically in preterm infants, and that clinicians must consider the risks and benefits of therapy 5.
- An older study from 1982 found that metoclopramide was effective in treating functional feeding intolerance and gastric stasis in selected preterm infants, with no untoward side effects noted 6.
Adverse Effects of Metoclopramide in Premature Infants
- Adverse effects of metoclopramide in premature infants have been reported, including dystonic reactions 3, irritability, drowsiness, oculogyric crisis, emesis, and apnea 4.
- The potential for adverse effects may be due to excessive serum concentrations of the drug resulting from prolonged plasma clearance in preterm infants 3.
Clinical Implications
- The use of metoclopramide for GERD in premature infants should be approached with caution, considering the potential for adverse effects and the lack of systematic evidence supporting its efficacy in this population 2, 3, 4, 5.
- Clinicians should carefully weigh the risks and benefits of therapy and consider alternative treatments, such as preventive measures and other medications, before prescribing metoclopramide to premature infants 5.