Metoclopramide in gastroesophageal reflux of infancy.

This study examined the effect of metoclopramide on lower esophageal sphincter (LES) pressure, and frequency and duration of reflux episodes in 28 children (mean age (+/- SD) 9 +/- 11 months) referred for evaluation of gastroesophageal reflux (GER). Esophageal manometry was performed before and after one intravenous dose of metoclopramide (0.125 mg/kg), and esophageal pH was monitored over a 24-hour baseline period, followed by oral metoclopramide therapy (0.125 mg/kg four times a day, for 24 hours.) During pH monitoring, patients received diet for age and were kept in the prone position with the head elevated 45 degrees while sleeping. Eight patients entered a 6-month double-blind, placebo-controlled trial of metoclopramide. Metoclopramide significantly (P = 0.04) increased end-expiratory LES pressure, from 14.9 +/- 7.5 mm Hg to 18.6 +/- 6.8 mm Hg. However, there was a significant (P less than 0.05) increase in the number of reflux episodes/24 hours, and no significant change in percentage of time pH was less than 4, number of episodes lasting greater than 5 minutes, or the longest episode of reflux between the 24-hour baseline and M periods. LES pressure did not correlate well with any of these measurements (r = 0.2). In the controlled trial, the three patients receiving metoclopramide, but none of those receiving placebo, were withdrawn by their parents because of exacerbation of GER symptoms and marked irritability (P = 0.01). In the placebo group, symptoms improved in four infants, but did not change in one. The use of metoclopramide in the treatment of GER of infancy needs to be reconsidered.